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BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Mikyung Kim, Jung-Eun Kim, Hye-Yoon Lee, Ae-Ran Kim, Hyo-Ju Park, O-Jin Kwon, Eun-Jung Kim, Yeon-Cheol Park, Byung-Kwan Seo, Jung Hyo Cho, Joo-Hee Kim

Published in: BMC Complementary Medicine and Therapies | Issue 1/2017

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Abstract

Background

Cancer-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/design

A 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.

Discussion

The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue.

Trial registration

Clinical Research Information Service KCT0002170. Registered 16 December 2016.
Appendix
Available only for authorised users
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Metadata
Title
Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial
Authors
Mikyung Kim
Jung-Eun Kim
Hye-Yoon Lee
Ae-Ran Kim
Hyo-Ju Park
O-Jin Kwon
Eun-Jung Kim
Yeon-Cheol Park
Byung-Kwan Seo
Jung Hyo Cho
Joo-Hee Kim
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2017
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-017-1856-3

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