Article Text
Abstract
Introduction Cancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue.
Methods and analysis The present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3 g of Sipjeondaebo-tang or a placebo three times a day for 56 days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer—QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14 weeks.
Ethics and dissemination This study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary’s Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference.
Trial registration number NCT02858856; Pre-results.
- herbal medicine
- breast tumours
- clinical trials
- complementary medicine
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Footnotes
Contributors CC and SK have written the first manuscript for this trial and they will contribute to monitoring this trial. YK and MK have contributed to the development of the protocol. BHJ and YCS have edited the first manuscript. SGK has conducted all the procedures for this protocol. All authors have read and approved the final manuscript.
Funding This work was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number HI12C1889). The management, analysis and reporting of study will be conducted independently by the study investigators.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The Institutional Review Board of the Catholic Kwandong University International St. Mary’s Hospital approved the study (reference IS16MNSI0011).
Provenance and peer review Not commissioned; externally peer reviewed.