Please use this identifier to cite or link to this item: https://doi.org/10.1186/s13063-020-04810-4
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dc.titleA 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
dc.contributor.authorYap, N.Y.
dc.contributor.authorLoo, W.S.
dc.contributor.authorZheng, H.F.
dc.contributor.authorTan, Q.M.
dc.contributor.authorTan, T.K.
dc.contributor.authorQuek, L.Y.P.
dc.contributor.authorTan, C.J.
dc.contributor.authorToh, Y.L.
dc.contributor.authorNg, C.C.
dc.contributor.authorAng, S.K.
dc.contributor.authorTan, V.K.M.
dc.contributor.authorHo, H.K.
dc.contributor.authorChew, L.
dc.contributor.authorLoh, K.W.-J.
dc.contributor.authorTan, T.J.Y.
dc.contributor.authorChan, A.
dc.date.accessioned2021-08-25T14:05:00Z
dc.date.available2021-08-25T14:05:00Z
dc.date.issued2020
dc.identifier.citationYap, N.Y., Loo, W.S., Zheng, H.F., Tan, Q.M., Tan, T.K., Quek, L.Y.P., Tan, C.J., Toh, Y.L., Ng, C.C., Ang, S.K., Tan, V.K.M., Ho, H.K., Chew, L., Loh, K.W.-J., Tan, T.J.Y., Chan, A. (2020). 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. Trials 21 (1) : 909. ScholarBank@NUS Repository. https://doi.org/10.1186/s13063-020-04810-4
dc.identifier.issn17456215
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/199290
dc.description.abstractBackground: 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. © 2020, The Author(s).
dc.publisherBioMed Central Ltd
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScopus OA2020
dc.subjectCancer survivors
dc.subjectCancer-related fatigue
dc.subjectQuality of life
dc.subjectRandomized controlled trial
dc.subjectTraditional Chinese medicine
dc.typeArticle
dc.contributor.departmentDEPT OF PHARMACY
dc.description.doi10.1186/s13063-020-04810-4
dc.description.sourcetitleTrials
dc.description.volume21
dc.description.issue1
dc.description.page909
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