Acupuncture in chemotherapy-induced dysgeusia (AcuDysg): study protocol of a randomised controlled trial.

INTRODUCTION: Dysgeusia is a common side effect of chemotherapy in patients with cancer, but to date, there is no effective treatment. Many patients with cancer request complementary medicine treatment in addition to their cancer treatments, and acupuncture is highly accepted for patients with cancer; however, evidence regarding the effectiveness of acupuncture for dysgeusia is scarce.The study investigates the effectiveness of an additional dysgeusia-specific acupuncture plus self-acupressure intervention compared with supportive acupuncture plus self-acupressure intervention alone for chemotherapy-induced dysgeusia in patients with cancer. METHODS AND ANALYSIS: This is a multicentre, randomised, controlled and two-armed parallel-group, single-blind trial involving 130 patients. Both groups will receive eight sessions of acupuncture treatment over a period of 8 weeks and will be trained to perform self-acupressure (eLearning combined with therapist instruction) at predefined acupressure points once a day during the whole treatment period. Patients in the control group will receive supportive routine care acupuncture and self-acupressure treatment only; in addition to this treatment, the intervention group will receive the dysgeusia-specific acupuncture and acupressure within the same treatment session. The primary outcome is the perceived dysgeusia over 8 weeks, measured weekly after the acupuncture treatment. Secondary outcomes include the indices from the objective taste and smell test, weight loss, perceived dysgeusia, fatigue, distress, nausea and vomiting, odynophagia, xerostomia and polyneuropathy, as well as quality of life at the different time points. ETHICS AND DISSEMINATION: The study has been approved by the Cantonal Ethics Committee (CEC) (Kanton Zürich Kantonale Ethikkommission) (approval no. KEK-ZH-Nr. 2020-01900). The results will be submitted to a peer-reviewed journal for publication. TRIAL REGISTRATION NUMBERS: DRKS00023348, SNCTP000004128.

Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) with Non-Pharmacological Interventions: Clinical Recommendations from a Systematic Scoping Review and an Expert Consensus Process.

Background: Most individuals affected by cancer who are treated with certain chemotherapies suffer of CIPN. Therefore, there is a high patient and provider interest in complementary non-pharmacological therapies, but its evidence base has not yet been clearly pointed out in the context of CIPN. Methods: The results of a scoping review overviewing the published clinical evidence on the application of complementary therapies for improving the complex CIPN symptomatology are synthesized with the recommendations of an expert consensus process aiming to draw attention to supportive strategies for CIPN. The scoping review, registered at PROSPERO 2020 (CRD 42020165851), followed the PRISMA-ScR and JBI guidelines. Relevant studies published in Pubmed/MEDLINE, PsycINFO, PEDro, Cochrane CENTRAL, and CINAHL between 2000 and 2021 were included. CASP was used to evaluate the methodologic quality of the studies. Results: Seventy-five studies with mixed study quality met the inclusion criteria. Manipulative therapies (including massage, reflexology, therapeutic touch), rhythmical embrocations, movement and mind-body therapies, acupuncture/acupressure, and TENS/Scrambler therapy were the most frequently analyzed in research and may be effective treatment options for CIPN. The expert panel approved 17 supportive interventions, most of them were phytotherapeutic interventions including external applications and cryotherapy, hydrotherapy, and tactile stimulation. More than two-thirds of the consented interventions were rated with moderate to high perceived clinical effectiveness in therapeutic use. Conclusions: The evidence of both the review and the expert panel supports a variety of complementary procedures regarding the supportive treatment of CIPN; however, the application on patients should be individually weighed in each case. Based on this meta-synthesis, interprofessional healthcare teams may open up a dialogue with patients interested in non-pharmacological treatment options to tailor complementary counselling and treatments to their needs.

[Mind-body medicine in integrative uro-oncology : Studies and areas of application]. / Mind-body-Medizin in der integrativen Uroonkologie : Studienlage und Einsatzgebiete.

BACKGROUND: Mind-body medicine (MBM) complements somatically oriented medical practice with behavioral and lifestyle-oriented approaches: Thus, health-promoting attitudes and behaviors are strengthened in everyday life. In integrative oncology, it helps promote emotional and physical well-being. RESEARCH QUESTION: Guideline recommendations and the current study situation in integrative uro-oncology are presented. RESULTS: During and after completion of primary therapy, mindfulness-based stress reduction (MBSR) shows positive effects on anxiety, stress, and fatigue. However, it appears that the offer needs to be better tailored to the needs of prostate cancer patients. The effects of yoga are well documented, especially on fatigue, quality of life, and sexual function. Prostate cancer patients also showed a significantly increased immune response after completing a yoga intervention. Tai Ji Quan/Qigong improve quality of life, fatigue, and other symptoms. Hypnosis-especially in the palliative setting-mitigates anxiety, and relaxation techniques alleviate sleep problems and nausea/vomiting. Multimodal services improve quality of life on numerous levels. Higher resilience correlates with better quality of life and stronger male self-esteem. CONCLUSIONS: MBSR alleviates many symptoms but needs to be adapted to the needs of prostate cancer patients; yoga and Tai Ji Chuan/Qigong alleviate fatigue and improve quality of life. Hypnosis and relaxation training reduce nausea/vomiting, and improve sleep and anxiety. Resilience promotion is important to support oncological patients.

Safety of acupuncture in oncology: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Acupuncture is frequently used to treat the side effects of cancer treatment, but the safety of this intervention remains uncertain. The current meta-analysis was conducted to assess the safety of acupuncture in oncological patients. METHODS: The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated an with increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and an active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or drop out because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials. CONCLUSIONS: The current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology. LAY SUMMARY: According to this analysis, acupuncture is a safe therapy for the treatment of patients with cancer. Acupuncture seems to be safe compared with sham acupuncture and active controls.

Effects of an Interdisciplinary Integrative Oncology Group-Based Program to Strengthen Resilience and Improve Quality of Life in Cancer Patients: Results of a Prospective Longitudinal Single-Center Study.

BACKGROUND: Patients with cancer receiving oncological treatment often suffer from a reduced quality of life (QoL) and resilience. OBJECTIVES: The aim of this study was to evaluate the effect of an interdisciplinary integrative oncology group-based program on resilience and quality of life in patients with cancer during or after conventional oncological therapy. METHODS: This prospective longitudinal single-center study evaluated the resilience (Resilience Scale), quality of life (EORTC-QLQ C30), anxiety, depression (Hospital Anxiety and Depression Scale), and distress levels (Distress Thermometer) of 60 patients with cancer who participated in a 10-week interdisciplinary integrative oncology group-based program during or after cancer treatment in outpatient clinics. An average of 12 (range 11-13) patients participated in each 10-week group. The program included recommendations for diet, stress management, relaxation, and exercise, as well as naturopathic self-help strategies and psychosocial support. RESULTS: There were slight increases in global quality of life scores (week 0: 58.05 ± 20.05 vs week 10: 63.13 ± 18.51, n = 59, P = .063, d = -.25) and resilience scores (week 0: 63.50 ± 13.14 vs week 10: 66.15 ± 10.17, n = 52, P = .222, d = -.17) after the group program compared to before; however, these changes were not statistically significant and had small effect sizes. Patients with at least moderate anxiety symptoms (P = .022, d = .42) and low resilience (P = .006, d = -.54) benefited most from the program. The patients reported no relevant side effects or adverse events from the program. CONCLUSIONS: No significant effects on global quality of life or resilience were found in the general sample; notably, patients with anxiety and low initial resilience benefited the most from the program.

[Creating evidence for naturopathic nursing interventions in oncology - a systematic approach]. / Generierung von Evidenz zu naturheilkundlichen Pflegeinterventionen in der Onkologie ­ ein systematisches Verfahren.

BACKGROUND: Nurses working in oncology use a wide range of naturopathic interventions in their daily practice to alleviate symptoms and improve the quality of life of oncological patients. However, there is no external evidence for many of these interventions. Due to a lack of scientific studies in the field, the aim of the project described here is to develop a standardized procedure to generate evidence on naturopathic interventions, on the basis of which recommendations may be derived for nursing practice. METHOD: The systematic procedure presented here was developed by the working group (WG) Integrative Nursing in Oncology over a period of four years in an iterative process. This process is based on the expert panel members' experience with the development of guidelines and/or quality instruments such as practice standards. RESULT: The systematic methodological approach presented here consists of three successive steps where internal and external evidence have been combined: a scoping review, a structured consensus process with oncology nurses to collect and evaluate naturopathic interventions, and finally a further supplementary literature review based on additional findings of the consensus conference. The procedure was successfully carried out for mucositis, insomnia, fatigue, hand-foot syndrome and chemotherapy-induced polyneuropathy. CONCLUSION: Through the step-by-step synthesis of internal evidence and the best available external evidence, the evidence base for naturopathic nursing interventions in oncology can be generated and practice recommendations derived. The procedure represents a successful theory-practice transfer through structured cooperation between (nursing) scientists and nursing practitioners. In terms of the AWMF classification, the practice recommendations developed in the process described fall somewhere in between an S1 guideline (informal consensus of an expert group) and an S2e guideline (evidence-based).

Efficacy and Safety of Auricular Acupuncture for the Treatment of Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

Among women, breast cancer is the most commonly diagnosed cancer worldwide. Sleep problems impair 40-70% of breast cancer survivors. This randomized controlled trial evaluates the effect of auricular acupuncture on sleep quality in breast cancer survivors suffering from insomnia. Fifty-two female breast cancer survivors with insomnia (mean age 55.73 ± 8.10 years) were randomized either to 10 treatments of auricular acupuncture within five weeks (n = 26), or to a single session of psychoeducation plus an insomnia advice booklet (n = 26). The primary outcome was sleep quality (measured by the Pittsburgh Sleep Quality Index) at week 5. Secondary outcomes were inflammation parameter (interleukin-6), stress, anxiety, depression, quality of life, and fatigue at week 5, and sleep quality, stress, anxiety, depression, quality of life, and fatigue 17 and 29 weeks after randomization. Intention-to-treat analysis showed a significantly stronger increase in sleep quality in the auricular acupuncture group compared to the psychoeducation group (p = 0.031; η2p = 0.094) at week 5. Furthermore, auricular acupuncture improved stress (p = 0.030; η2p = 0.094), anxiety (p = 0.001; η2p = 0.192), and fatigue (p = 0.006; η2p = 0.148) at week 5 compared to psychoeducation. No significant group difference was found concerning the other outcomes at week 5, or in any outcome at week 17 or week 29. No serious adverse events occurred during the study period. In conclusion, a semi-standardized group auricular acupuncture might be an effective and safe intervention in treating insomnia in breast cancer survivors in the short term, and may reduce stress, anxiety, and fatigue as well. Long-term effects remain questionable.

The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women's response to integrative breast cancer treatment.

BACKGROUND: Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients' quality and quantity of life. METHODS: INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo-/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. DISCUSSION: This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. TRIAL REGISTRATION: German Clinical Trial Register DRKS00014852 . Retrospectively registered at July 4th, 2018.

Nursing Procedures for the Prevention and Treatment of Mucositis Induced by Cancer Therapies: Clinical Practice Guideline Based on an Interdisciplinary Consensus Process and a Systematic Literature Search.

BACKGROUND: Patients with cancer receiving tumor therapy often suffer from oral mucositis. OBJECTIVES: The aim of this project was to summarize experiences with nursing procedures by experts in integrative oncology and to establish recommendations for nursing interventions that can prevent or cure mucositis. METHODS: The study design was an interdisciplinary consensus process based on a systematic literature search. RESULTS: The panel discussed and agreed on 19 nursing procedures, which included mouthwashes, such as teas, supplements, oil applications, and different kinds of ice cubes to suck, as well as flaxseed solution, propolis, and mare milk. Twelve interventions were classified as effective, with effectiveness for OraLife, propolis, sea buckthorn pulp oil, marshmallow root tea also for xerostomia, Helago chamomile oil, mare milk, and Saliva Natura rated as highly effective in clinical experience. In the systematic literature search, a total of 12 out of 329 randomized controlled trials and meta-analyses on chamomile (n = 3), Calendula (n = 1) and sage (n = 1), propolis (n = 2), and sucking ice cubes (cryotherapy; n = 5) met all inclusion criteria. Trial evidence for effectiveness in oral mucositis was revealed for propolis and cryotherapy. CONCLUSIONS: The current evidence supports the use of some nursing procedures (f.e. propolis for 2 and 3 grade mucositis) for improving oral mucositis during cancer therapies. There is still a need to define general clinical practice guidelines for the supportive treatment of mucositis, as well as for more interdisciplinary research in this area.