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This study is a phase 2, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of a Traditional Chinese Medicine decoction, the modified from Xiang Bei Yang Rong Tang (香贝养荣汤) in alleviating cancer related fatigue in breast cancer survivors.
Cancer-related fatigue (CRF) is a distressing, persistent and subjective sense of physical, emotional, or cognitive tiredness related to cancer or its treatment. Up to a quarter of breast cancer survivors (BCS) experience clinically significant CRF. Currently there is a lack of effective conventional pharmacological intervention for treating this condition. Traditional Chinese Medicine (TCM) could be alternative therapy for managing CRF.
This study is a phase 2, randomized, double-blinded, placebo-controlled trial to examine the efficacy and safety of a TCM decoction, the modified Xiang Bei Yang Rong Tang (香贝养荣汤) in alleviating CRF in BCS. Study participants recruited from National Cancer Centre Singapore (NCCS) will be randomized to receive either the Xiang Bei Yang Rong Tang (XBYRT) or placebo decoction. Participants will take their assigned decoction daily for a duration of 8 weeks and will be assessed using patient reported outcome (PRO) questionnaires. PROs used are the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ 30) for QOL, the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) for fatigue and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Version 3 for cognitive abilities. The changes in scores measured by these assessment tools will be compared between the XBYRT intervention and placebo groups. Blood biomarkers such as inflammatory cytokines, mitochondrial DNA and oxidative stress markers will also be evaluated in the study participants. Additionally, adverse events or serious adverse events in participants will be monitored for safety.
Results from this study will provide a better understanding on the role of TCM in managing CRF.
Modified Xiang Bei Yangrong Tang, Placebo
National Cancer Centre Singapore
Not yet recruiting
National University, Singapore
Published on BioPortfolio: 2019-10-01T07:55:11-0400
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