Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial.

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.

• Authors: Chunhoo Cheon, Sohyeon Kang, Youme Ko, Mia Kim, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 7 Pg. e021242 (07 06 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 29982213 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Chemical References

• Antineoplastic Agents
• Drugs, Chinese Herbal
• Plant Extracts
• juzentaihoto

Topics

• Adult
• Antineoplastic Agents (pharmacology, therapeutic use)
• Breast Neoplasms (complications, drug therapy, physiopathology, psychology)
• Cross-Over Studies
• Double-Blind Method
• Drugs, Chinese Herbal (pharmacology, therapeutic use)
• Fatigue (drug therapy, etiology, physiopathology, psychology)
• Female
• Herbal Medicine
• Humans
• Male
• Middle Aged
• Phytotherapy
• Pilot Projects
• Plant Extracts (pharmacology, therapeutic use)
• Quality of Life
• Randomized Controlled Trials as Topic
• Treatment Outcome