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

Ning Yi Yap, Wei Sheng Loo, Huang Fang Zheng, Quan Ming Tan, Tze Kiat Tan, Leona Yan Peng Quek, Chia Jie Tan, Yi Long Toh, Chiu Chin Ng, Seng Kok Ang, Veronique Kiak Mien Tan, Han Kiat Ho, Lita Chew, Kiley Wei-Jen Loh, Tira Jing Ying Tan, Alexandre Chan, Ning Yi Yap, Wei Sheng Loo, Huang Fang Zheng, Quan Ming Tan, Tze Kiat Tan, Leona Yan Peng Quek, Chia Jie Tan, Yi Long Toh, Chiu Chin Ng, Seng Kok Ang, Veronique Kiak Mien Tan, Han Kiat Ho, Lita Chew, Kiley Wei-Jen Loh, Tira Jing Ying Tan, Alexandre Chan

Abstract

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.gov NCT04104113 . Registered on 26 September 2019.

Keywords: Cancer survivors; Cancer-related fatigue; Quality of life; Randomized controlled trial; Traditional Chinese medicine.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of the study design and assessment time points
Fig. 2
Fig. 2
SPIRIT figure for the enrolment, interventions and assessments of the study

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