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.
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
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.


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


BACKGROUND
Current controlled trials ISRCTN12702489 , 14 August, 2013.
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. lichen0701326@163.com.
Chen
C
Li
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. guowangyang@sina.com.
GuoWang
G
Yang
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. yumingwei1120@163.com.
MingWei
M
Yu
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. xymlfc@163.com.
YongMei
Y
Xu
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. me1988xuena@126.com.
Na
N
Xue
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. kkwp263@163.com.
Nan
N
Nan
Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No. 23, Back Road of Art Gallery, Beijing, Dong Cheng District, 10010, China. wangxiaomin_bhtcm@126.com.
XiaoMin
X
Wang
D001943:Breast Neoplasms / Q000150:complications* / Q000175:diagnosis; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D004365:Drugs, Chinese Herbal; C534230:shugan jianpi