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.
Author(s): Li C(1), Yang G(2), Yu M(3), Xu Y(4), Xue N(5), Nan N(6), Wang X(7).
Affiliation(s): Author information:
(1)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. (2)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. (3)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. (4)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. (5)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.
(6)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. (7)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.
Publication date & source: 2015, Trials. , 16:192
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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