Acupuncture for breast cancer-related lymphedema: a randomized controlled trial.

PURPOSE: Approximately 20% of breast cancer survivors develop breast cancer-related lymphedema (BCRL), and current therapies are limited. We compared acupuncture (AC) to usual care wait-list control (WL) for treatment of persistent BCRL. METHODS: Women with moderate BCRL lasting greater than six months were randomized to AC or WL. AC included twice weekly manual acupuncture over six weeks. We evaluated the difference in circumference and bioimpedance between affected and unaffected arms. Responders were defined as having a decrease in arm circumference difference greater than 30% from baseline. We used analysis of covariance for circumference and bioimpedance measurements and Fisher's exact to determine the proportion of responders. RESULTS: Among 82 patients, 73 (89%) were evaluable for the primary endpoint (36 in AC, 37 in WL). 79 (96%) patients received lymphedema treatment before enrolling in our study; 67 (82%) underwent ongoing treatment during the trial. We found no significant difference between groups for arm circumference difference (0.38 cm greater reduction in AC vs. WL, 95% CI - 0.12 to 0.89, p = 0.14) or bioimpedance difference (1.06 greater reduction in AC vs. WL, 95% CI - 5.72 to 7.85, p = 0.8). There was also no difference in the proportion of responders: 17% AC versus 11% WL (6% difference, 95% CI - 10 to 22%, p = 0.5). No severe adverse events were reported. CONCLUSIONS: Our acupuncture protocol appeared to be safe and well tolerated. However, it did not significantly reduce BCRL in pretreated patients receiving concurrent lymphedema treatment. This regimen does not improve upon conventional lymphedema treatment for breast cancer survivors with persistent BCRL.

Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial.

PURPOSE: Hematopoietic stem cell transplantation (HCT) is potentially curative for a number of hematologic malignancies, but is associated with high symptom burden. We conducted a randomized sham-controlled trial (RCT) to evaluate efficacy and safety of acupuncture as an integrative treatment for managing common symptoms during HCT. METHODS: Adult patients with multiple myeloma undergoing high-dose melphalan followed by autologous HCT (AHCT) were randomized to receive either true or sham acupuncture once daily for 5 days starting the day after chemotherapy. Patients and clinical evaluators, but not acupuncturists, were blinded to group assignment. Symptom burden, the primary outcome was assessed with the MD Anderson Symptom Inventory (MDASI) at baseline, during transplantation, and at 15 and 30 days post transplantation. RESULTS: Among 60 participants, true acupuncture produced nonsignificant reductions in overall MDASI core symptom scores and symptom interference scores during transplantation (P = .4 and .3, respectively), at 15 days (P = .10 and .3), and at 30 days posttransplantation (P = .2 and .4) relative to sham. However, true acupuncture was significantly more efficacious in reducing nausea, lack of appetite, and drowsiness at 15 days (P = .042, .025, and .010, respectively). Patients receiving sham acupuncture were more likely to increase pain medication use posttransplantation (odds ratio 5.31, P = .017). CONCLUSIONS: Acupuncture was well tolerated with few attributable adverse events. True acupuncture may prevent escalation of symptoms including nausea, lack of appetite, and drowsiness experienced by patients undergoing AHCT, and reduce the use of pain medications. These findings need to be confirmed in a future definitive study. TRIAL REGISTRATION: NCT01811862.

Acupuncture Research at Memorial Sloan Kettering Cancer Center.

Acupuncture may help treat specific cancer-related symptoms. Here, we summarize our clinical trials that sought to determine acupuncture's role in managing cancer-related symptoms. Trials have been conducted to determine acupuncture's ability to mitigate cancer-related symptoms including dyspnea, fatigue, xerostomia, lymphedema, hot flashes, postoperative ileus, pain and dysfunction after neck dissection, and postthoracotomy pain. Published studies indicate that acupuncture versus placebo acupuncture failed to reduce cancer-related dyspnea. Both true and sham acupuncture alleviated fatigue slightly, but no significant differences between groups emerged. Compared with sham acupuncture, our research showed that acupuncture significantly improved saliva production in patients with xerostomia and significantly reduced lymphedema patients' arm circumference in a pilot study. However, acupuncture failed to significantly reduce hot flashes and was no more successful than sham acupuncture in reducing postoperative ileus. Significant reductions in pain and dysfunction occurred in cancer patients after neck dissection. In a feasibility study, acupuncture was found to be acceptable to lung cancer patients and did not interfere with standard postoperative care. In summary, acupuncture is a potential candidate for the treatment of some important cancer-related symptoms. Large clinical trials and research to investigate mechanistic pathways are warranted.

Serum 25-hydroxy vitamin D and survival in advanced colorectal cancer: a retrospective analysis.

Higher serum 25-hydroxy vitamin D [25(OH)D] levels are associated with decreased colorectal cancer (CRC) incidence. In this retrospective study of Stage IV CRC patients, we evaluate whether 25(OH)D levels at diagnosis correlate with survival. Stored sera from carcinoembryonic antigen (CEA) measurements obtained between February 2005 and March 2006 were screened. The first 250 patients with CEA ± 30 days of Stage IV CRC diagnosis were included. Serum 25(OH)D levels were determined and categorized as adequate ≥ 30 ng/mL, or deficient <30 ng/mL. Multivariable Cox regression models controlling for albumin and Eastern Cooperative Oncology Group performance status were used to investigate whether higher 25(OH)D levels were associated with prolonged survival. A total of 207 patients (83%) were vitamin D-deficient (median = 21 ng/mL), with deficiencies significantly more likely among non-Hispanic black patients (P = 0.009). Higher levels were associated with prolonged survival in categorical variable analysis: adequate vs. deficient, hazard ratio = 0.61, 95% confidence interval = 0.38-0.98, P = 0.041. A majority of newly diagnosed Stage IV CRC patients are vitamin D-deficient. Our data suggest that higher 25(OH)D levels are associated with better overall survival. Clinical trials to determine whether aggressive vitamin D repletion would improve outcomes for vitamin D-deficient CRC patients are warranted.

Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.

BACKGROUND: Myelodysplastic syndromes (MDS) are characterized by ineffective erythropoiesis with dysplastic bone marrow leading to peripheral cytopenia, risk of infection, and progression to acute myelogenous leukemia. Maitake mushroom beta-glucan, a dietary supplement, stimulates hematopoietic progenitor cell differentiation, granulocyte colony-stimulating factor production, and recovery of peripheral blood leukocytes after bone marrow injury. This phase II trial examined the effects of Maitake on innate immune function in MDS. METHODS: Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease received oral Maitake extract at 3 mg/kg twice daily for 12 weeks. Primary endpoints included neutrophil count and function tested as endogenous or stimulated neutrophil production of reactive oxygen species (ROS) by flow cytometry compared with age-matched healthy controls (HC). ROS activators were Escherichia coli, phorbol ester, and the bacterial peptide N-formylmethionyl-leucyl-phenylalanine (fMLP). Complete blood counts, chemistry panels, iron studies, and monocyte function were evaluated. RESULTS: Of 21 patients enrolled, 18 completed the study and were evaluable. Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021). Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03). Asymptomatic eosinophilia occurred in 4 patients (p = 0.014). Other changes in albumin, hemoglobin, and total protein were not clinically relevant. CONCLUSIONS: Maitake was well tolerated. Enhanced in vitro neutrophil and monocyte function following treatment demonstrate that Maitake has beneficial immunomodulatory potential in MDS. Further study is warranted.

Integrative oncology: an overview.

Integrative oncology, the diagnosis-specific field of integrative medicine, addresses symptom control with nonpharmacologic therapies. Known commonly as "complementary therapies" these are evidence-based adjuncts to mainstream care that effectively control physical and emotional symptoms, enhance physical and emotional strength, and provide patients with skills enabling them to help themselves throughout and following mainstream cancer treatment. Integrative or complementary therapies are rational and noninvasive. They have been subjected to study to determine their value, to document the problems they ameliorate, and to define the circumstances under which such therapies are beneficial. Conversely, "alternative" therapies typically are promoted literally as such; as actual antitumor treatments. They lack biologic plausibility and scientific evidence of safety and efficacy. Many are outright fraudulent. Conflating these two very different categories by use of the convenient acronym "CAM," for "complementary and alternative therapies," confuses the issue and does a substantial disservice to patients and medical professionals. Complementary and integrative modalities have demonstrated safety value and benefits. If the same were true for "alternatives," they would not be "alternatives." Rather, they would become part of mainstream cancer care. This manuscript explores the medical and sociocultural context of interest in integrative oncology as well as in "alternative" therapies, reviews commonly-asked patient questions, summarizes research results in both categories, and offers recommendations to help guide patients and family members through what is often a difficult maze. Combining complementary therapies with mainstream oncology care to address patients' physical, psychologic and spiritual needs constitutes the practice of integrative oncology. By recommending nonpharmacologic modalities that reduce symptom burden and improve quality of life, physicians also enable patients to play a role in their care. Critical for most patients, this also improves the physician-patient relationship, the quality of cancer care, and the well-being of patients and their families.

Psychiatric benefits of integrative therapies in patients with cancer.

Integrative oncology uses non-pharmacological adjuncts to mainstream care to manage physical, emotional, and psychological symptoms experienced by cancer survivors. Depression, anxiety, fatigue and pain are among the common, often burdensome symptoms that can occur in clusters, deplete patient morale, interfere with treatment plans, and hamper recovery. Patients already seek various modalities on their own to address a broad range of problems. Legitimate complementary therapies offered at major cancer institutions improve quality of life, speed recovery, and optimize patient support. They also augment the benefits of psychiatric interventions, due to their ability to increase self-awareness and improve physical and psychological conditioning. Further, these integrated therapies provide lifelong tools and develop skills that patients use well after treatment to develop self-care regimens. The active referral of patients to integrative therapies achieves three important objectives: complementary care is received from therapists experienced in working with cancer patients, visits become part of the medical record, allowing treatment teams to guide individuals in maximizing benefit, and patients are diverted from useless or harmful 'alternatives.' We review the reciprocal physical and psychiatric benefits of exercise, mind-body practices, massage, acupuncture, and music therapy for cancer survivors, and suggest how their use can augment mainstream psychiatric interventions.

Echinacea purpurea (L.) Moench modulates human T-cell cytokine response.

The study objective was to evaluate the composition of a neutral and weakly acidic water-soluble extract from Echinacea purpurea (L.) Moench (EchNWA) previously shown to modify murine influenza infection, and to assess immunomodulatory effects on human T-cells. EchNWA extract from fresh aerial parts was extracted with water, ethanolic precipitation, and size-exclusion chromatography. The chemical profile of EchNWA was characterized by chromatography (size-exclusion, HPLC, GC-MS), and small molecule fingerprint analysis performed by HPLC-PDA. Jurkat T-cells at high and low cell density were pretreated or not with doses of EchNWA, followed by activation with phorbol 12-myristate 13-acetate plus ionomycin (PMA+I). Interleukin-2 (IL-2) and interferon gamma (IFNg) cytokine secretions were measured by multi-cytokine luminex technology. Results showed that EchNWA contains 80% polysaccharides, predominantly a 10kDa entity; phenolic compounds, cynarin, cichoric and caftaric acids, but no detectable alkylamides. Cytokine production required stimulation and was lower after PMA+I activation in high-density compared to low-density conditions. EchNWA mediated a strong dose-dependent enhancement of high-density T-cell production of IL-2 and IFNg response to PMA+I. EchNWA alone did not stimulate T-cells. EchNWA enhanced mean fluorescence intensity of IL-2 in Jurkat T-cells activated by PMA+1 or ionomycin alone. Conversely EchNWA mediated modest but significant suppression of IFNg response and reduced the percentage of CD25+ T-cells under low-density conditions. Conclusions are that EchNWA polysaccharides, but not phenolic compounds have dose-related adjuvant effects on human T-cell cytokine responses characterized by enhancing and suppressive effects that are regulated by T-cell density.

The role of physical activity in cancer prevention, treatment, recovery, and survivorship.

An informal review of literature on exercise and cancer was undertaken in order to examine the role of exercise in cancer prevention, treatment, rehabilitation, and late survivorship. Population-wide studies show that cancer incidence decreases with increasing physical activity levels. Exercise can decrease the side effects of anticancer therapy, and can aid in recovery and rehabilitation following chemotherapy, radiation, and surgery. Observational studies of breast, colon, and prostate cancer survivors show robust associations between post-diagnosis exercise and decreased cancer-specific mortality. In addition, all-cause mortality in cancer survivors decreases with increasing amounts of exercise. The amount and intensity of exercise required to measure a survival benefit appear to vary by primary tumor type. Decreased breast cancer mortality is seen with the equivalent of 3 hours of walking per week, and decreased colon cancer mortality with 6 hours of walking per week. For these tumors, more vigorous exercise may not improve survival. However, after a prostate cancer diagnosis, more intense exercise is associated with superior survival when compared with walking. The mechanisms behind these differences remain to be elucidated. Further research is also needed to determine the various amounts and intensities of exercise required for optimum cancer prevention, recovery, and survival.

Complementary or alternative medicine in cancer care-myths and realities.

Complementary therapies are adjuncts to mainstream care, used primarily for symptom control and to enhance physical and emotional strength during and after mainstream cancer treatment. These therapies are rational, noninvasive and evidence-based that have been subjected to study to determine their value, document the problems they aim to ameliorate and define the circumstances under which they are beneficial. By contrast, 'alternative' therapies are generally promoted as such-for use as actual antitumour treatments. Typically they lack biological plausibility and scientific evidence of safety and efficacy, and many are outright fraudulent. Combining the helpful complementary therapies with mainstream oncology care to address patients' physical, psychological and spiritual needs constitutes the practice of integrative oncology. By providing patients' nonpharmacological treatment modalities that reduce symptom burden and improve quality of life, physicians enable patients to have an active role in their care, which in turn improves the physician-patient relationship, the quality of cancer care and the well-being of patients and their families.

Complementary therapies and integrative medicine in lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.

BACKGROUND: Physicians are often asked about complementary therapies by patients with cancer, and data show that the interest in and use of these therapies among patients with cancer is common. Therefore, it is important to assess the current evidence base on the benefits and risks of complementary therapies (modalities not historically used in modern Western medicine). METHODS: A systematic literature review was carried out and recommendations were made according to the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines development methodology. RESULTS: A large number of randomized controlled trials, systematic reviews, and meta-analyses, as well as a number of prospective cohort studies, met the predetermined inclusion criteria. These trials addressed many different issues pertaining to patients with lung cancer, such as symptoms of anxiety, mood disturbance, pain, quality of life, and treatment-related side effects. The available data cover a variety of interventions, including acupuncture, nutrition, mind-body therapies, exercise, and massage. The body of evidence supports a series of recommendations. An evidenced-based approach to modern cancer care should integrate complementary therapies with standard cancer therapies such as surgery, radiation, chemotherapy, and best supportive care measures. CONCLUSIONS: Several complementary therapy modalities can be helpful in improving the overall care of patients with lung cancer.

Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study.

BACKGROUND: Current treatments for lymphedema after breast cancer treatment are expensive and require ongoing intervention. Clinical experience and our preliminary published results suggest that acupuncture is safe and potentially useful. This study evaluates the safety and potential efficacy of acupuncture on upper-limb circumference in women with lymphedema. METHODS: Women with a clinical diagnosis of breast cancer-related lymphedema (BCRL) for 0.5-5 years and with affected arm circumference ≥2 cm larger than unaffected arm received acupuncture treatment twice weekly for 4 weeks. Affected and unaffected arm circumferences were measured before and after each acupuncture treatment. Response, defined as ≥30% reduction in circumference difference between affected/unaffected arms, was assessed. Monthly follow-up calls for 6 months thereafter were made to document any complications and self-reported lymphedema status. RESULTS: Among 37 enrolled patients, 33 were evaluated; 4 discontinued due to time constraints. Mean reduction in arm circumference difference was 0.90 cm (95% CI, 0.72-1.07; P < .0005). Eleven patients (33%) exhibited a reduction of ≥30% after acupuncture treatment. Seventy-six percent of patients received all treatments; 21% missed 1 treatment, and another patient missed 2 treatments. During the treatment period, 14 of the 33 patients reported minor complaints, including mild local bruising or pain/tingling. There were no serious adverse events and no infections or severe exacerbations after 255 treatment sessions and 6 months of follow-up interviews. CONCLUSIONS: Acupuncture for BCRL appears safe and may reduce arm circumference. Although these results await confirmation in a randomized trial, acupuncture can be considered for women with no other options for sustained arm circumference reduction.

Acupuncture for the treatment of post-chemotherapy chronic fatigue: a randomized, blinded, sham-controlled trial.

PURPOSE: Many cancer patients experience persistent fatigue after the completion of chemotherapy. A previous single-arm study provided evidence for an effect of acupuncture in this population. We conducted a randomized controlled trial to determine whether acupuncture reduces post-chemotherapy chronic fatigue more effectively than sham acupuncture. METHODS: Cancer patients reporting significant fatigue persisting for at least 2 months following the completion of chemotherapy were randomized to receive once weekly true or sham acupuncture for 6 weeks. Fatigue was evaluated before and after treatment using the Brief Fatigue Inventory (BFI, the primary endpoint). Secondary endpoints included the Hospital Anxiety and Depression Scale (HADS) and Functional Assessment of Cancer Treatment-General (FACT-G) scores. RESULTS: One hundred one patients were randomized with 74 (34 true acupuncture; 40 sham control) evaluated for the primary endpoint. BFI scores fell by about one point between baseline and follow-up in both groups with no statistically significant difference between groups. HADS and FACT-G scores also improved in both groups, but there was no significant difference between groups. Patients in the sham acupuncture group crossed over to receive true acupuncture in week 7. No long-term reduction of fatigue scores was observed at the 6-month evaluation. CONCLUSIONS: True acupuncture as provided in this study did not reduce post-chemotherapy chronic fatigue more than did sham acupuncture. The study is limited by the number of patients lost to follow-up. We also cannot exclude the possibility that a more intensive treatment regimen may be more effective.

A phase II, randomized, controlled trial of acupuncture for reduction of Postcolectomy Ileus.

PURPOSE: Postoperative ileus (POI) prolongs hospital stay and increases risk of postoperative complications. We conducted a randomized, sham-controlled trial to evaluate whether acupuncture reduces POI more effectively than sham acupuncture. METHODS: Colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first 3 postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first 3 postoperative days. RESULTS: Ninety patients were randomized. Eighty-one received the allocated intervention: 39 in the true acupuncture group and 42 in the sham acupuncture group, all evaluated for the primary endpoint. The mean time to GI-3 was 149 h [standard deviation (SD) 71 h] and 146 (SD 62 h) after surgery for the acupuncture group and the sham acupuncture group (difference between means -2 h; 95 % confidence interval -31, 26; p = 0.9). No significant differences were found between groups for secondary endpoints. CONCLUSIONS: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture. The study was limited by a standard deviation much larger than expected, suggesting that a study with a larger sample size might be required.

Cancer quackery: the persistent popularity of useless, irrational 'alternative' treatments.

At a time when many readily believe that vaccines cause autism, or that government scientists created AIDS as a weapon of black genocide, it is not surprising that medical quackery, especially cancer quackery, remains a flourishing and lucrative business throughout the developed world. This review provides a brief recap of its history and an overview of the various types of unproven or disproved cancer therapies popular now in the United States and elsewhere.

Palliative care: Progress, needs, and challenges.

Palliative care is increasingly available and the importance of its role increasingly recognized. International work toward making palliative care a basic human right underscores the growing need to ensure comfort and pain relief for the terminally ill. The organizational structures in place for providing such care vary greatly within and across countries; even definition of the term is not uniform. The World Health Organization (WHO) definition includes the statement that palliative care "... intends neither to hasten nor postpone death...", thus illustrating varying socio-cultural perceptions. In addition to cultural differences, other challenges include clinical, economic, and varying institutionalized systems and practices in patient care.This is a commentary on http://www.ijhpr.org/content/1/1/9/

Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer.

PURPOSE: Spiritual well-being and sense of meaning are important concerns for clinicians who care for patients with cancer. We developed Individual Meaning-Centered Psychotherapy (IMCP) to address the need for brief interventions targeting spiritual well-being and meaning for patients with advanced cancer. PATIENTS AND METHODS: Patients with stage III or IV cancer (N = 120) were randomly assigned to seven sessions of either IMCP or therapeutic massage (TM). Patients were assessed before and after completing the intervention and 2 months postintervention. Primary outcome measures assessed spiritual well-being and quality of life; secondary outcomes included anxiety, depression, hopelessness, symptom burden, and symptom-related distress. RESULTS: Of the 120 participants randomly assigned, 78 (65%) completed the post-treatment assessment and 67 (56%) completed the 2-month follow-up. At the post-treatment assessment, IMCP participants demonstrated significantly greater improvement than the control condition for the primary outcomes of spiritual well-being (b = 0.39; P <.001, including both components of spiritual well-being (sense of meaning: b = 0.34; P = .003 and faith: b = 0.42; P = .03), and quality of life (b = 0.76; P = .013). Significantly greater improvements for IMCP patients were also observed for the secondary outcomes of symptom burden (b = -6.56; P < .001) and symptom-related distress (b = -0.47; P < .001) but not for anxiety, depression, or hopelessness. At the 2-month follow-up assessment, the improvements observed for the IMCP group were no longer significantly greater than those observed for the TM group. CONCLUSION: IMCP has clear short-term benefits for spiritual suffering and quality of life in patients with advanced cancer. Clinicians working with patients who have advanced cancer should consider IMCP as an approach to enhance quality of life and spiritual well-being.