Evidence map›Paper›PMID 33187543›Full record

ArticleTrials2020

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 and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04104113 (HEalth-Related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using TraditionAL Chinese Medicine), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04104113 phase2unknown statusnot on this map

HEalth-Related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using TraditionAL Chinese Medicine: The HERBAL Trial

TypeinterventionalSponsorNational University of SingaporeRan2019 to 2022Enrolled80ConditionsCancer, Fatigue, Cognitive ImpairmentArmsModified Xiang Bei Yang Rong Tang, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Traditional Chinese Medicine for Breast Cancer: A Review.Breast cancer (Dove Medical Press) · 2023
    Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 2 countries.

Ning Yi YapDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.ORCID http://orcid.org/0000-0002-6280-9521
Wei Sheng LooDepartment of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore.
Huang Fang ZhengSingapore Thong Chai Medical Institution, Singapore, Singapore.
Quan Ming TanSingapore Thong Chai Medical Institution, Singapore, Singapore.
Tze Kiat TanSingapore Thong Chai Medical Institution, Singapore, Singapore.
Leona Yan Peng QuekSingapore Thong Chai Medical Institution, Singapore, Singapore.
Chia Jie TanDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.
Yi Long TohDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.
Chiu Chin NgDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.
Seng Kok AngDepartment of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore.
Veronique Kiak Mien TanDivision of Surgery & Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Han Kiat HoDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.
Lita ChewDepartment of Pharmacy, National University of Singapore, Singapore, Singapore.
Kiley Wei-Jen LohDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Tira Jing Ying TanDivision of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.
Alexandre ChanDepartment of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore. a.chan@uci.edu.
National Cancer Centre Singapore · SGNational University of Singapore · SGUniversity of California, Irvine · US

Funding

Singapore Ministry of Health Traditional Chinese Medicine Research Grant TCMRG-3-NUS-01
6 · The paper itself

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. 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.

Indexed as

Drugs, Chinese HerbalNeoplasmsFatigueHumansMedicine, Chinese TraditionalQuality of LifeRandomized Controlled Trials as TopicSurvivorsTreatment OutcomeDrugs, Chinese HerbalCancer-related fatigueCancer survivorsQuality of lifeRandomized controlled trialTraditional Chinese medicine

Identifiers

PMID33187543
PMCPMC7664081
OpenAlexW3100513777

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.