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

Autor: Tze Kiat Tan, Tira Jing Ying Tan, Ning Yi Yap, Yi Long Toh, Veronique Kiak Mien Tan, Wei Sheng Loo, Quan Ming Tan, Leona Yan Peng Quek, Chiu Chin Ng, Seng Kok Ang, Kiley Wei-Jen Loh, Alexandre Chan, Huang Fang Zheng, Chia Jie Tan, Han Kiat Ho, Lita Chew
Rok vydání: 2020
Předmět:
Chinese Herbal
Cancer survivors
Medicine (miscellaneous)
Traditional Chinese medicine
Cardiorespiratory Medicine and Haematology
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Neoplasms
Pharmacology (medical)
Survivors
Medicine
Chinese Traditional
Cancer-related fatigue
Fatigue
Randomized Controlled Trials as Topic
Cancer
lcsh:R5-920
Rehabilitation
Drugs
Treatment Outcome
6.1 Pharmaceuticals
030220 oncology & carcinogenesis
Medicine
Patient Safety
medicine.symptom
lcsh:Medicine (General)
medicine.medical_specialty
Clinical Trials and Supportive Activities
Clinical Sciences
Placebo
03 medical and health sciences
Clinical Research
General & Internal Medicine
Internal medicine
Complementary and Integrative Health
medicine
Humans
Adverse effect
business.industry
Prevention
Chinese Traditional
Evaluation of treatments and therapeutic interventions
medicine.disease
Clinical trial
Cardiovascular System & Hematology
business
030217 neurology & neurosurgery
Drugs
Chinese Herbal
Zdroj: Trials, Vol 21, Iss 1, Pp 1-10 (2020)
Trials, vol 21, iss 1
Trials
ISSN: 1745-6215
Popis: Background Cancer-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. Methods This 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. Discussion Efficacy 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 number ClinicalTrials.govNCT04104113. Registered on 26 September 2019
Databáze: OpenAIRE
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