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.
Highlights
Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life
The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue
Considering that the clinical effects of these drugs are unclear and the risk of adverse drug reactions are of high concern, especially for long-term use, no specific drug is currently recommended as a primary therapeutic option for cancerrelated fatigue [17, 19, 20]
Summary
Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. As the prevalence of cancer and the survival rate of patients increase, the quality of life (QOL) of cancer survivors and the symptoms affecting QOL are gaining increased attention [1]. Cancer-related fatigue reduces the level of energy and decreases the QOL of cancer patients, negatively affecting the return-to-work rate of cancer survivors [5, 6]. It seriously damages the QOL of the families in addition to cancer patients in terms of physical, social, economic, psychological and spiritual aspects [7]. The definition of cancerrelated fatigue is completely dependent on the subjective sense of tiredness felt by the patient, and it is easy to overlook when the patient does not actively report the symptom [8]
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