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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effects of traditional Chinese medicine Shu Gan Jian Pi granules on patients with breast cancer and cancer-related fatigue: study protocol for a randomized controlled trial

Authors: Chen Li, GuoWang Yang, MingWei Yu, YongMei Xu, Na Xue, Nan Nan, XiaoMin Wang

Published in: Trials | Issue 1/2015

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Abstract

Background

Cancer-related fatigue (CRF) is a common and often long-lasting symptom for many breast cancer survivors. Evidence for its management is scarce. However, the Traditional Chinese Medicine (TCM) Shu Gan Jian Pi (SGJP) granules is an effective and practical therapy for CRF.

Methods/Design

We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether the SGJP granules can effectively manage CRF. Breast cancer survivors experiencing fatigue within 5 years of primary treatment completion will be enrolled and randomly assigned to Group S (SGJP) or Group P (placebo). The primary outcome measures will include Revised Piper Fatigue Scale score. Outcome measures will be collected at baseline and at weeks 2, 4, and 8.

Discussion

This study’s findings may contribute to the development of an effective intervention for CRF.

Trial registration

Current controlled trials ISRCTN12702489, 14 August, 2013.
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Metadata
Title
Effects of traditional Chinese medicine Shu Gan Jian Pi granules on patients with breast cancer and cancer-related fatigue: study protocol for a randomized controlled trial
Authors
Chen Li
GuoWang Yang
MingWei Yu
YongMei Xu
Na Xue
Nan Nan
XiaoMin Wang
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0723-0

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