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/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.