Research: KIM and COLLEAGUES,

Listed in Issue 260

Abstract

KIM and COLLEAGUES, 1. Clinical Research Division, Korea Institute of Oriental Medicine, 1672, Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea; 2. College of Korean Medicine, Dongguk University, 123, Dongdae-ro, Gyeongju, Gyeongsangbuk-do, 38066, Republic of Korea; 3. Department of Acupuncture & Moxibustion, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea; 4. Department of Internal Medicine, College of Traditional Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, Republic of Korea; 5. Clinical Research Division, Korea Institute of Oriental Medicine, 1672, Yuseongdae-ro, Yuseong-gu, Daejeon, 34054, Republic of Korea. jhkim714v@gmail.com set out the design of a multi-center, three-armed parallel, randomized controlled trial to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue.

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.

Methodology

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 centres. 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.

Results

Outcome Measures: 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.

Conclusion

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.

References

Kim M1, Kim JE1, Lee HY1, Kim AR1, Park HJ1, Kwon OJ1, Kim EJ2, Park YC3, Seo BK3, Cho JH4, Kim JH5. Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial. BMC Complement Altern Med. 17(1):353. Jul 5 2017. DOI: 10.1186/s12906-017-1856-3. https://www.ncbi.nlm.nih.gov/pubmed/28679410

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