Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial

Abstract

BackgroundCancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue.Methods/designA multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 scores, and Montreal Cognitive Assessment scores between groups. Safety will be assessed by monitoring adverse events at each visit.DiscussionThe results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue.Trial registrationClinical Research Information Service KCT0002170. Registered 16 December 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-017-1856-3) contains supplementary material, which is available to authorized users.

Can Moxibustion Treatment Improve Vertical Jump Biomechanics?

“…This data would suggest that the fatigue inducing exercise had very little effect on ground reaction force jump time. As the results from jump 1 baseline and jump 2 no treatment shows a slight decrease in time this would agree with the theory that fatigue can have a detrimental effect on performance [21]. There were significant differences discovered between the non-treatment and moxibustion treatment jump times (P=0.045).…”

Moxibustion for treating cancer‐related fatigue: A multicenter, assessor‐blinded, randomized controlled clinical trial

“…Detailed protocol for moxibustion has been published previously. 24 The participants in the UC group did not receive moxibustion treatment and maintained their usual treatment and self‐care. Regardless of their allocated groups, all participants were provided a brochure on the management of CRF.…”

“…Statistical analysis was done by an independent statistician blinded to group allocation as described previously. 24 Full analysis set (FAS) was used for the analysis, and the multiple imputation method was adopted for incomplete data sets. Using SAS® Version 9.4 (SAS institute.…”

Grain‐sized moxibustion promotes NK cell antitumour immunity by inhibiting adrenergic signalling in non–small cell lung cancer

“…Moxibustion has been shown to have a good effect on treating tumour-related symptoms, such as fatigue, 3,4 pain, [5][6][7] anorexia 8 and depression, 9 and on alleviating surgery-and chemotherapy-induced adverse effects. 10 However, its antitumour effect on NSCLC remains largely unexplored.…”