1. A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial
- Author
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Yap, Ning Yi, Loo, Wei Sheng, Zheng, Huang Fang, Tan, Quan Ming, Tan, Tze Kiat, Quek, Leona Yan Peng, Tan, Chia Jie, Toh, Yi Long, Ng, Chiu Chin, Ang, Seng Kok, Tan, Veronique Kiak Mien, Ho, Han Kiat, Chew, Lita, Loh, Kiley Wei-Jen, Tan, Tira Jing Ying, and Chan, Alexandre
- Subjects
Health Services and Systems ,Nursing ,Health Sciences ,Complementary and Integrative Health ,Rehabilitation ,Prevention ,Clinical Research ,Clinical Trials and Supportive Activities ,Patient Safety ,Cancer ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Drugs ,Chinese Herbal ,Fatigue ,Humans ,Medicine ,Chinese Traditional ,Neoplasms ,Quality of Life ,Randomized Controlled Trials as Topic ,Survivors ,Treatment Outcome ,Randomized controlled trial ,Cancer survivors ,Quality of life ,Cancer-related fatigue ,Traditional Chinese medicine ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
BackgroundCancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Traditional Chinese medicine (TCM) could be a potential therapeutic option for CRF. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors. This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors.MethodsThis is a single centre, randomized, double-blind, placebo-controlled, parallel trial. Eighty cancer survivors will be recruited and randomized to receive the XBYRT or placebo decoction, in a ratio of 1:1. Participants will consume the XBYRT/placebo decoction daily for 8 weeks and undergo assessments at baseline and 4, 8 and 10 weeks after baseline. The participants will be assessed for patient-reported outcomes (PRO), blood biomarkers and adverse events at each time point. The primary outcome is the overall health and QOL status, at 8 weeks follow-up. The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO. The incidence of adverse events and the effects of the XBYRT decoction on blood biomarkers associated with CRF will also be evaluated.DiscussionEfficacy and safety outcomes from this trial will provide important clinical data to guide future large-scale randomized controlled trials, and the evaluation of the objective blood biomarkers can help to delineate the biological mechanisms of CRF.Trial registration numberClinicalTrials.gov NCT04104113 . Registered on 26 September 2019.
- Published
- 2020