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1.
Contemp Clin Trials Commun ; 38: 101269, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38380342

ABSTRACT

Background: Pragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention. Methods: Study activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations. Results: Between January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch. Conclusions: A multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making. Trial: Registration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/.

2.
Explore (NY) ; 2023 Nov 10.
Article in English | MEDLINE | ID: mdl-37977922

ABSTRACT

OBJECTIVE: To examine the relationship between Contemplative Medicine training and clinician burnout. METHODS: Clinicians underwent a 12 month training program in Contemplative Medicine, which addresses several of the "Well-being 2.0" framework elements. An uncontrolled pre and post test study design was used with the validated Maslach Burnout Inventory (MBI) as the study tool to evaluate efficacy of the program. RESULTS: Participants demonstrated improvement in burnout levels after the intervention. There were significant differences at the 0.05 significance level or better on all three scales of the MBI instrument when comparing baseline to follow-up responses, including emotional exhaustion, depersonalization, and sense of personal accomplishment. Particular improvement was noted in the "personal accomplishment" domain, with p < 0.01 when comparing baseline and follow-up responses. CONCLUSION: The results of this study suggest that Contemplative Medicine training is a viable approach for improving clinician burnout and concretely implementing the "Well-being 2.0" framework.

3.
J Pain Symptom Manage ; 65(5): 367-377, 2023 05.
Article in English | MEDLINE | ID: mdl-36738867

ABSTRACT

OBJECTIVES: To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics. BACKGROUND: The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations. METHODS: Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed. RESULTS: A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics. CONCLUSION: The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management.


Subject(s)
Neoplasms , Sleep Wake Disorders , Humans , Depression/epidemiology , Depression/diagnosis , Fatigue/epidemiology , Fatigue/complications , Neoplasms/epidemiology , Neoplasms/therapy , Neoplasms/complications , Prevalence , Reproducibility of Results , Sleep Wake Disorders/epidemiology
4.
Palliat Support Care ; : 1-2, 2022 Dec 20.
Article in English | MEDLINE | ID: mdl-36537296
5.
Palliat Med Rep ; 3(1): 206-210, 2022.
Article in English | MEDLINE | ID: mdl-36203715

ABSTRACT

Patients with serious illnesses may experience existential and psychosocial distress contributing to their pain and suffering. Addressing existential distress is challenging and may require a multidisciplinary approach. Often, providers feel uncomfortable or ill equipped to care for patients suffering from this distress. In the sample case, the patient has a life-limiting disease and is concerned about his family forgetting him, experiencing loss of dignity and narrative foreclosure. Loss of dignity is sensing hopelessness and worthlessness and a loss of self-determination. Narrative foreclosure is the premature conviction that one's life story has effectively ended. Beneficial interventions include meaning-centered psychotherapy and dignity therapy (DT). Both have an underlying theme of attempting to reverse the narrative foreclosure for patients with serious illnesses and maintain a sense of meaning in life. In addition, patients can be referred to palliative care to enhance coping and decrease depressive symptoms. Dr. Harvey Chochinov has outlined a framework that clinicians can use to care for their patients in a compassionate manner to specifically combat meaninglessness. In DT, a generativity document is created for the patient and their loved ones as part of the treatment along with the opportunity to answer the dignity conserving question. Success of this route of intervention includes greater will to live, reductions in stress, and benefits perceived by family. This article aims to give a framework to treat patients with serious illnesses experiencing psychosocial and/or existential distress.

6.
J Natl Cancer Inst ; 114(3): 458-466, 2022 03 08.
Article in English | MEDLINE | ID: mdl-34508602

ABSTRACT

BACKGROUND: The symptom burden associated with cancer and its treatment can negatively affect patients' quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. METHODS: In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to "opt-in" to receive a call, but the protocol was later modified so they had to "opt-out" if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. RESULTS: Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. CONCLUSIONS: Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.


Subject(s)
Neoplasms , Quality of Life , Anxiety , Humans , Neoplasms/complications , Neoplasms/psychology , Neoplasms/therapy , Nurse's Role , Palliative Care/methods
8.
BMJ Support Palliat Care ; 11(3): 264-270, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33441387

ABSTRACT

BACKGROUND: Pain is one of the most common and problematic symptoms encountered by patients with cancer. Due to the multifactorial aetiology, pain management of these patients frequently requires multidisciplinary interventions including conventional support and specialty palliative care. Acupuncture has been identified as a possible adjunctive therapy for symptom management in cancer pain, and there is currently no systematic review focused solely on the evidence of acupuncture on cancer pain in palliative care. OBJECTIVE: To critically analyse currently available publications regarding the use of acupuncture for pain management among patients with cancer in palliative care settings. METHODS: Multiple academic databases were searched from inception to 29 October 2020. Randomised controlled trials involving acupuncture in palliative care for treatment of cancer-related pain were synthesised. Data were extracted by two independent reviewers, and methodological quality of each included study was assessed using the Oxford Centre for Evidence-Based Medicine (OCEBM) 2011 Levels of Evidence. RESULTS: Five studies (n=189) were included in this systematic review. Results indicated a favourable effect of acupuncture on pain relief in palliative care for patients with cancer. According to OCEBM 2011 Levels of Evidence, they were level 2 in one case (20%), level 3 in two cases (40%) and level 4 in the remaining (40%). Low-level evidence adversely affects the reliability of findings. CONCLUSIONS: Acupuncture may be an effective and safe treatment associated with pain reduction in the palliative care of patients with cancer. Further high-quality, adequately powered studies are needed in the future.


Subject(s)
Acupuncture Therapy , Cancer Pain , Neoplasms , Cancer Pain/therapy , Humans , Neoplasms/complications , Neoplasms/therapy , Pain Management , Palliative Care , Reproducibility of Results
9.
Support Care Cancer ; 29(2): 833-840, 2021 Feb.
Article in English | MEDLINE | ID: mdl-32500206

ABSTRACT

PURPOSE: The current project was developed to obtain natural history information regarding cisplatin-induced peripheral neuropathy in males with testicular/germ cell cancers and to compare such neuropathy data with similarly obtained data in patients receiving other chemotherapy drugs in similarly conducted clinical trials. METHODS: Patients without baseline neuropathy symptoms, who were initiating cisplatin-based chemotherapy, completed the EORTC CIPN 20 patient-reported instrument to evaluate chemotherapy-induced peripheral neuropathy (CIPN). Results were compared with EORTC CIPN 20 data obtained from independent study sets regarding patients receiving (1) paclitaxel, (2) combined paclitaxel and carboplatin, (3) oxaliplatin, or (4) a combination of doxorubicin and cyclophosphamide (AC). The last study set of patients on AC was selected to evaluate the use of EORTC CIPN 20 data in patients receiving chemotherapy not known to cause CIPN. RESULTS: Cisplatin-induced neuropathy was more similar to neuropathy in patients receiving oxaliplatin than in those receiving paclitaxel. The cisplatin and oxaliplatin groups exhibited the coasting phenomenon and more prominent upper extremity symptoms than lower extremity symptoms during chemotherapy administration weeks. In contrast, paclitaxel-treated patients did not, on average, exhibit the coasting phenomenon; additionally, lower extremity symptoms were more prominent during the weeks when paclitaxel was administered. Cisplatin-induced neuropathy was less severe than was seen in patients in the other two groups, potentially because the cisplatin-receiving patients were younger. Patients receiving AC did not report substantial EORTC CIPN 20 changes. CONCLUSION: Understanding neuropathy similarities and differences with various chemotherapy agents may help elucidate CIPN processes and facilitate means to prevent and/or treat established CIPN. TRIAL REGISTRATION: NCT02677727.


Subject(s)
Antineoplastic Agents/adverse effects , Cisplatin/adverse effects , Peripheral Nervous System Diseases/chemically induced , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Carboplatin/administration & dosage , Carboplatin/adverse effects , Cisplatin/administration & dosage , Clinical Trials as Topic , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Female , Humans , Male , Middle Aged , Neoplasms, Germ Cell and Embryonal/drug therapy , Oxaliplatin/adverse effects , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Peripheral Nervous System Diseases/diagnosis , Peripheral Nervous System Diseases/pathology , Testicular Neoplasms/drug therapy , Young Adult
10.
Trials ; 21(1): 480, 2020 Jun 05.
Article in English | MEDLINE | ID: mdl-32503661

ABSTRACT

BACKGROUND: The prevalence of inadequate symptom control among cancer patients is quite high despite the availability of definitive care guidelines and accurate and efficient assessment tools. METHODS: We will conduct a hybrid type 2 stepped wedge pragmatic cluster randomized clinical trial to evaluate a guideline-informed enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) care model. Teams of clinicians at five hospitals that care for patients with various cancers will be randomly assigned in steps to the E2C2 intervention. The E2C2 intervention will have two levels of care: level 1 will offer low-touch, automated self-management support for patients reporting moderate sleep disturbance, pain, anxiety, depression, and energy deficit symptoms or limitations in physical function (or both). Level 2 will offer nurse-managed collaborative care for patients reporting more intense (severe) symptoms or functional limitations (or both). By surveying and interviewing clinical staff, we will also evaluate whether the use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 technologies improves patient and clinical outcomes. Finally, we will conduct a mixed methods evaluation to identify disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer. DISCUSSION: The E2C2 intervention offers a pragmatic, scalable approach to delivering guideline-based symptom and function management for cancer patients. Since discrete EHR-imbedded algorithms drive defining aspects of the intervention, the approach can be efficiently disseminated and updated by specifying and modifying these centralized EHR algorithms. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03892967. Registered on 25 March 2019.


Subject(s)
Electronic Health Records , Medical Oncology/methods , Palliative Care/methods , Patient Care Team , Cluster Analysis , Humans , Medical Informatics/methods , Medical Oncology/standards , Multicenter Studies as Topic , Patient Reported Outcome Measures , Pragmatic Clinical Trials as Topic , Quality of Life , Self-Management
11.
Support Care Cancer ; 25(11): 3537-3544, 2017 11.
Article in English | MEDLINE | ID: mdl-28634656

ABSTRACT

PURPOSE: Clinical practice guidelines on chemotherapy-induced peripheral neuropathy (CIPN) use the NCI Common Terminology Criteria for Adverse Events (CTCAE), while recent clinical trials employ a potentially superior measure, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20), a patient-reported outcome (PRO). Practitioners and researchers lack guidance, regarding how QLQ-CIPN20 results relate to the traditional CTCAE during the serial assessment of patients undergoing chemotherapy. METHODS: Two large CIPN clinical trial datasets (538 patients) pairing QLQ-CIPN20 and CTCAE outcomes were analyzed using a multivariable linear mixed model with QLQ-CIPN20 score as the outcome variable, CTCAE grade as the main effect, and patient as random effect (accounting for internal correlation of serial measures). RESULTS: The association between QLQ-CIPN20 scores and CTCAE grades was strong (p < 0.0001), whereby patients with higher CTCAE grade had worse QLQ-CIPN20 scores. Some variation of QLQ-CIPN20 scores was observed based on drug, treatment, and cycle. While there was a marked difference in the mean QLQ-CIPN20 scores between CTCAE grades, the ranges of QLQ-CIPN20 scores within each CTCAE grade were large, leading to large overlap in CIPN20 scores across CTCAE grades. CONCLUSIONS: A strong positive association of QLQ-CIPN20 scores and CTCAE grade provides evidence of convergent validity as well as practical guidance, as to how to quantitatively interpret QLQ-CIPN20 scores at the study level in terms of the traditional CTCAE. The present results also highlight an important clinical caveat, specifically, that conversion of a specific QLQ-CIPN20 score to a specific CTCAE score may not be reliable at the level of an individual patient.


Subject(s)
Antineoplastic Agents/adverse effects , Carboplatin/adverse effects , Organoplatinum Compounds/adverse effects , Paclitaxel/adverse effects , Patient Reported Outcome Measures , Peripheral Nervous System Diseases/chemically induced , Adult , Aged , Female , Humans , Male , Middle Aged , Neoplasms/drug therapy , Oxaliplatin , Peripheral Nervous System Diseases/pathology , Physicians
12.
Support Care Cancer ; 25(11): 3407-3416, 2017 11.
Article in English | MEDLINE | ID: mdl-28551844

ABSTRACT

PURPOSE: Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Given that extensive animal data suggest that minocycline may prevent chemotherapy-induced neurotoxicity, the purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and the P-APS. METHODS: Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks and were randomized to receive minocycline 200 mg on day 1 followed by 100 mg twice daily or a matching placebo. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy to measure P-APS and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment, to measure CIPN. RESULTS: Forty-seven patients were randomized. There were no remarkable differences noted between the minocycline and placebo groups for the overall sensory neuropathy score of the EORTC QLQ-CIPN20 or its individual components, which evaluate tingling, numbness and shooting/burning pain in hands and feet. However, patients taking minocycline had a significant reduction in the daily average pain score attributed to P-APS (p = 0.02). Not only were no increased toxicities reported with minocycline, but there was a significant reduction in fatigue (p = 0.02). CONCLUSIONS: Results of this pilot study do not support the use of minocycline to prevent CIPN, but suggest that it may reduce P-APS and decrease fatigue; further study of the impact of this agent on those endpoints may be warranted.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Minocycline/therapeutic use , Paclitaxel/adverse effects , Peripheral Nervous System Diseases/chemically induced , Anti-Bacterial Agents/pharmacology , Double-Blind Method , Female , Humans , Middle Aged , Minocycline/pharmacology , Pilot Projects
13.
Support Care Cancer ; 24(12): 5059-5068, 2016 12.
Article in English | MEDLINE | ID: mdl-27534963

ABSTRACT

PURPOSE: Oxaliplatin and paclitaxel are commonly used chemotherapies associated with acute and chronic neuropathies. There is a need to better understand the similarities and differences of these clinical syndromes. METHODS: Neuropathy data were pooled from patients receiving adjuvant oxaliplatin and weekly paclitaxel or every 3 weeks of paclitaxel. Patients completed daily questionnaires after each chemotherapy dose and the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for patients with chemotherapy-induced peripheral neuropathy before each chemotherapy cycle and for 12 months post-treatment. RESULTS: Acute neuropathy symptoms from both drugs peaked around day 3. Acute symptoms experienced in cycle 1 predicted occurrence in subsequent cycles. Paclitaxel-induced acute symptoms were similar in intensity in each cycle and largely resolved between cycles. Oxaliplatin-induced acute symptoms were about half as severe in the first cycle as in later cycles and did not resolve completely between cycles. Both drugs caused a predominantly sensory chronic neuropathy (with numbness and tingling being more common than pain). Oxaliplatin-induced neuropathy worsened after the completion of treatment and began to improve 3 months post-treatment. In contrast, paclitaxel-induced neuropathy began improving immediately after chemotherapy cessation. During treatment, the incidence of paclitaxel sensory symptoms was similar in the hands and feet; with oxaliplatin, the hands were affected more than the feet. Both paclitaxel- and oxaliplatin-induced acute neurotoxicity appeared to predict the severity of chronic neuropathy, more prominently with oxaliplatin. CONCLUSIONS: Knowledge of the similarities and differences between neuropathy syndromes may provide insight into their underlying pathophysiology and inform future research to identify preventative treatment approaches.


Subject(s)
Antineoplastic Agents, Phytogenic/therapeutic use , Organoplatinum Compounds/therapeutic use , Paclitaxel/therapeutic use , Peripheral Nervous System Diseases/chemically induced , Adult , Aged , Antineoplastic Agents, Phytogenic/administration & dosage , Female , Humans , Male , Middle Aged , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Paclitaxel/administration & dosage , Peripheral Nervous System Diseases/drug therapy
14.
Support Care Cancer ; 24(6): 2807-14, 2016 06.
Article in English | MEDLINE | ID: mdl-27041741

ABSTRACT

PURPOSE: Chronic pain is a widespread and debilitating condition, encountered by physicians in a variety of practice settings. Although many pharmacologic and behavioral strategies exist for the management of this condition, treatment is often unsatisfactory. Scrambler Therapy is a novel, non-invasive pain modifying technique that utilizes trans-cutaneous electrical stimulation of pain fibers with the intent of re-organizing maladaptive signaling pathways. This review was conducted to further evaluate what is known regarding the mechanisms and mechanics of Scrambler Therapy and to investigate the preliminary data pertaining to the efficacy of this treatment modality. METHODS: The PubMed/Medline, SCOPUS, EMBASE, and Google Scholar databases were searched for all articles published on Scrambler Therapy prior to November 2015. All case studies and clinical trials were evaluated and reported in a descriptive manner. RESULTS: To date, 20 reports, of varying scientific quality, have been published regarding this device; all but one small study, published only as an abstract, provided results that appear positive. CONCLUSION: The positive findings from preliminary studies with Scrambler Therapy support that this device provides benefit for patients with refractory pain syndromes. Larger, randomized studies are required to further evaluate the efficacy of this approach.


Subject(s)
Chronic Pain/therapy , Electric Stimulation Therapy/methods , Electric Stimulation Therapy/instrumentation , Humans
15.
Support Care Cancer ; 24(3): 1071-8, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26248652

ABSTRACT

PURPOSE: Previous pilot data suggested that venlafaxine could prevent acute and chronic oxaliplatin-related neuropathy. The purpose of this randomized, placebo-controlled, double-blinded pilot study was to obtain additional data to support conducting a phase III trial to test the use of venlafaxine to prevent oxaliplatin neurotoxicity. METHODS: Fifty patients, scheduled to undergo oxaliplatin-based therapy (FOLFOX) for stages II-III (67%) or stage IV (33%) colon cancer, were randomized to receive venlafaxine extended release (37.5 mg) or placebo, twice daily, through their last dose of oxaliplatin and then titrated off. Neurotoxicity was evaluated via several patient- and physician-reported measures, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) instrument. RESULTS: Baseline patient characteristics were equivalent for the two arms, with a median age of 60 years. There was a trend toward benefit for the venlafaxine arm, when evaluated by the oxaliplatin-specific neuropathy scale and by acute neuropathy measures of throat discomfort and discomfort swallowing cold liquids, the latter only for the first two oxaliplatin doses. These trends were outweighed by a lack of any such trends in all other measurements including the following: (1) the CIPN20 sensory subscale (P = 0.55, primary endpoint), physician-completed NCI CTCAE assessment, or cumulative administered oxaliplatin doses (median 716 vs 631 mg for placebo and venlafaxine, respectively, P = 0.34). CONCLUSIONS: The present study neither supports the use of venlafaxine for preventing oxaliplatin-induced neuropathy in clinical practice nor the initiation of a phase III trial to investigate venlafaxine in this setting.


Subject(s)
Organoplatinum Compounds/adverse effects , Peripheral Nervous System Diseases/chemically induced , Serotonin and Noradrenaline Reuptake Inhibitors/therapeutic use , Venlafaxine Hydrochloride/therapeutic use , Double-Blind Method , Female , Humans , Male , Middle Aged , Oxaliplatin , Pilot Projects , Quality of Life , Serotonin and Noradrenaline Reuptake Inhibitors/administration & dosage , Venlafaxine Hydrochloride/administration & dosage
16.
Support Care Cancer ; 24(2): 547-553, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26155765

ABSTRACT

PURPOSE: Paclitaxel can cause an acute pain syndrome (P-APS), considered to be an acute form of neuropathy and chronic chemotherapy-induced peripheral neuropathy (CIPN). Anecdotal reports suggested that gabapentin may be helpful in the prevention of these toxicities. The purpose of this pilot study was to obtain data to support or refute the utility of pregabalin for the prevention of P-APS and CIPN. METHODS: Patients scheduled to receive weekly paclitaxel (80 mg/m(2)/dose) were randomized 1:1 to receive pregabalin 75 mg or a placebo, twice daily, during the 12 weeks of chemotherapy. Patients completed the European Organization of Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20 questionnaire at baseline, prior to each dose of paclitaxel and monthly for 6 months post-treatment. Patients completed a post-paclitaxel questionnaire for 6 days after each dose of paclitaxel and an acute pain syndrome symptom questionnaire on day 8. The primary end point was to determine the effect of pregabalin on the maximum of the worst acute pain scores for the week following paclitaxel administration for cycle 1. RESULTS: Forty-six patients were randomly assigned to the treatment or placebo arm. There was no suggestion of a difference between the two study arms with regard to P-APS measures. While there was a suggestion that pregabalin decreased numbness, there was no suggestion that it decreased tingling, pain, or the EORTC QLQ-CIPN20 subscale scores. There were no evident toxicity differences between the two study arms. CONCLUSIONS: The results of this pilot trial do not support that pregabalin is helpful for preventing P-APS or paclitaxel-associated CIPN.


Subject(s)
Acute Pain/prevention & control , Hypesthesia/prevention & control , Paclitaxel/adverse effects , Paresthesia/prevention & control , Peripheral Nervous System Diseases/prevention & control , Pregabalin/therapeutic use , Acute Pain/chemically induced , Adult , Aged , Amines/therapeutic use , Cyclohexanecarboxylic Acids/therapeutic use , Female , Gabapentin , Humans , Hypesthesia/chemically induced , Male , Middle Aged , Neoplasms/drug therapy , Paclitaxel/therapeutic use , Paresthesia/chemically induced , Peripheral Nervous System Diseases/chemically induced , Pilot Projects , Placebos , Quality of Life , Surveys and Questionnaires , gamma-Aminobutyric Acid/therapeutic use
17.
J Natl Compr Canc Netw ; 13(9): 1097-101, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26358793

ABSTRACT

Substantial research efforts have focused on methods of treating and preventing oxaliplatin-associated neuropathy, the dose-limiting toxicity associated with this drug. Administration of intravenous calcium and magnesium (CaMg) before and after oxaliplatin has been the most studied approach to preventing oxaliplatin-induced neuropathy. Although early reports demonstrated potential benefit, subsequent larger trials failed to confirm the efficacy of CaMg in preventing this adverse effect. This article explores how accumulating evidence for and against the use of CaMg for preventing oxaliplatin-induced neuropathy has impacted clinical practice.


Subject(s)
Antineoplastic Agents/adverse effects , Calcium/therapeutic use , Magnesium/therapeutic use , Organoplatinum Compounds/adverse effects , Peripheral Nervous System Diseases/prevention & control , Practice Patterns, Physicians' , Administrative Claims, Healthcare , Antineoplastic Agents/administration & dosage , Biomedical Research , Cetuximab/administration & dosage , Cisplatin/administration & dosage , Humans , Minnesota , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Peripheral Nervous System Diseases/chemically induced , Practice Patterns, Physicians'/statistics & numerical data , Practice Patterns, Physicians'/trends , Retrospective Studies , Translational Research, Biomedical
18.
J Clin Oncol ; 33(30): 3416-22, 2015 Oct 20.
Article in English | MEDLINE | ID: mdl-26282635

ABSTRACT

PURPOSE: Given that the clinical course of oxaliplatin-induced neuropathy is not well defined, the current study was performed to better understand clinical parameters associated with its presentation. METHODS: Acute and chronic neuropathy was evaluated in patients receiving adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) on study N08CB (North Central Cancer Treatment Group, Alliance). Acute neuropathy was assessed by having patients complete daily questionnaires for 6 days with each cycle of FOLFOX. Before each dose of FOLFOX and as long as 18 months after chemotherapy cessation, chronic neurotoxicity was assessed with use of the 20-item, European Organisation for Research and Treatment of Cancer quality-of-life questionnaire for patients with chemotherapy-induced peripheral neuropathy. RESULTS: Three hundred eight (89%) of the 346 patients had at least one symptom of acute neuropathy with the first cycle of FOLFOX; these symptoms included sensitivity to touching cold items (71%), sensitivity to swallowing cold items (71%), throat discomfort (63%), or muscle cramps (42%). Acute symptoms peaked at day 3 and improved, although they did not always resolve completely between treatments. These symptoms were about twice as severe in cycles 2 through 12 as they were in cycle 1. For chronic neurotoxicity, tingling was the most severe symptom, followed by numbness and then pain. During chemotherapy, symptoms in the hands were more prominent than they were in the feet; by 18 months, symptoms were more severe in the feet than they were in the hands. Patients with more severe acute neuropathy during the first cycle of therapy experienced more chronic sensory neurotoxicity (P < .0001). CONCLUSION: Acute oxaliplatin-induced neuropathy symptoms do not always completely resolve between treatment cycles and are only half as severe on the first cycle as compared with subsequent cycles. There is a correlation between the severities of acute and chronic neuropathies.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Neurotoxicity Syndromes/etiology , Neurotoxicity Syndromes/pathology , Organoplatinum Compounds/adverse effects , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/pathology , Acute Disease , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Calcium Compounds/therapeutic use , Chronic Disease , Colonic Neoplasms/drug therapy , Double-Blind Method , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Humans , Leucovorin/administration & dosage , Leucovorin/adverse effects , Magnesium Compounds/therapeutic use , Neurotoxicity Syndromes/prevention & control , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Peripheral Nervous System Diseases/prevention & control
19.
Support Care Cancer ; 23(4): 943-51, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25245776

ABSTRACT

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of chemotherapy, needs better effective treatments. Preliminary data support the use of Scrambler therapy, a device which treats pain via noninvasive cutaneous electrostimulation, for the treatment of CIPN. The current manuscript reports data from a pilot trial, performed to investigate the effect of Scrambler therapy for the treatment of established CIPN. METHODS: Eligible patients had CIPN symptoms of ≥1 month duration with tingling and/or pain ≥4/10 during the prior week. Patients were treated with Scrambler therapy to the affected area(s) for up to ten daily 30-min sessions. Symptoms were monitored using a neuropathy questionnaire consisting of numerical analog scales ranging from 0 to 10, daily before therapy as well as weekly for 10 weeks after therapy. Descriptive summary statistics formed the basis of data analysis. RESULTS: Thirty-seven patients were enrolled. Twenty-five patients were treated primarily on their lower extremities while 12 were treated primarily on their upper extremities. There was a 53 % reduction in pain score from baseline to day 10; a 44 % reduction in tingling; and a 37 % reduction in numbness. Benefit appeared to last throughout 10 weeks of follow-up. There were no substantial adverse events. CONCLUSION: Preliminary data support that Scrambler therapy may be effective for the treatment of CIPN: a prospective placebo-controlled clinical trial should be performed.


Subject(s)
Antineoplastic Agents/adverse effects , Electric Stimulation Therapy/methods , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/therapy , Adult , Aged , Antineoplastic Agents/administration & dosage , Double-Blind Method , Female , Humans , Male , Middle Aged , Neoplasms/drug therapy , Pilot Projects , Prospective Studies , Treatment Outcome
20.
Cancer J ; 20(5): 313-8, 2014.
Article in English | MEDLINE | ID: mdl-25299140

ABSTRACT

Cancer-related fatigue is a common yet underappreciated problem with a significant impact on functional ability and quality of life. Practice guidelines mandate that all cancer patients and survivors be screened for cancer-related fatigue (CRF) at regular intervals. Comorbidities that could contribute to fatigue should be treated, and patients with moderate to severe fatigue should undergo a comprehensive evaluation. Nonpharmacologic interventions are important tools to combat CRF and should be incorporated into routine practice. Physical activity, educational interventions, and cognitive-behavioral therapy have the most supportive data and can be recommended to patients with confidence. From a practical standpoint, general education on CRF is something that most care providers can readily offer patients as part of routine care. Other interventions that appear promising but are as yet lacking convincing evidence include mindfulness-based stress reduction, yoga, and acupuncture. Reiki, Qigong, hypnosis, and music therapy may be worthy of further investigation.


Subject(s)
Fatigue/etiology , Fatigue/therapy , Neoplasms/complications , Disease Management , Fatigue/diagnosis , Humans , Physical Therapy Modalities , Psychotherapy
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