NCT04104113

Brief Summary

This study is a phase 2, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of a Traditional Chinese Medicine decoction, the modified Xiang Bei Yang Rong Tang, in alleviating cancer related fatigue in cancer survivors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2022

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

September 24, 2019

Last Update Submit

June 13, 2020

Conditions

CancerFatigueCognitive Impairment

Keywords

CancerCancer Related FatigueCognitive ImpairmentSurvivorshipTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Difference in Global Health Status (GHS) score

    Difference in Global Health Status (GHS) score from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between XBYRT interventional and placebo arms from baseline to 8 weeks after baseline. The GHS scale ranges in score from 0-100. A higher score represents a better quality of life

    8 weeks from baseline

Secondary Outcomes (7)

  • Difference in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores

    4, 8 and 10 weeks from baseline

  • Difference in Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 scores

    4, 8 and 10 weeks from baseline

  • Incidence of adverse events

    baseline, and 4, 8 and 10 weeks from baseline

  • Difference in EORTC QLQ-C30 version 3.0 Functional and Symptom scale scores

    4, 8 and 10 weeks from baseline

  • Mitochondrial DNA (mtDNA) content

    baseline, 4, 8 and 10 weeks from baseline

  • +2 more secondary outcomes

Study Arms (2)

XBYRT decoction

EXPERIMENTAL

Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules

Other: Modified Xiang Bei Yang Rong Tang

Placebo

PLACEBO COMPARATOR

Participants assigned to receive placebo (contains 5% of XBYRT) granules

Other: Placebo

Interventions

Modified Xiang Bei Yang Rong TangOTHER

Modified Xiang Bei Yang Rong Tang is a combination of 15 herbal components and it is available in granules form to be dissolved in hot water for consumption

XBYRT decoction
PlaceboOTHER

Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler

Placebo

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥21 years
  • Clinically diagnosed cancer (Stages I-III)
  • Completed surgery/chemotherapy/radiotherapy for at least 1 month
  • At least one month after starting on aromatase inhibitors or ovarian suppression for breast cancer survivors
  • Not expected to receive surgery/chemotherapy/radiotherapy next 10 weeks
  • Fatigue screening score ≥4 for past 7 days
  • Life expectancy ≥3 months
  • Patients satisfy TCM syndrome differentiation as qi and blood deficiency Experience 2 major symptoms coupled with typical tongue and pulse conditions; 2 major symptoms and 1 possible symptom coupled with tongue and pulse conditions; 1 major symptom and at least 2 possible symptoms coupled with tongue and pulse conditions
  • Able to read and understand English or Mandarin

You may not qualify if:

  • Cancer recurrence and/or metastasis
  • Untreated co-morbidities causing fatigue (e.g. Severe anaemia, thyroid disorder)
  • On medications that cause fatigue (e.g. beta blockers)
  • Patients on warfarin
  • Cancer survivors receiving adjuvant therapy during the study period. Aromatase inhibitors and anti-HER2 monoclonal antibodies are acceptable.
  • Receiving or planning to receive treatment from other TCM practitioners during the study period
  • Breast feeding or intending to conceive/get pregnant during the study treatment period
  • Patients who present with yin deficiency and deficiency syndromes (e.g. phlegm-dampness, blood stasis, toxic-heat and qi stagnation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

RECRUITING

Related Publications (2)

  • Chan A, Chan D, Ng DQ, Zheng HF, Tan QM, Tan CJ, Toh JHM, Yap NY, Toh YL, Ke Y, Wang ECA, Lim QPN, Ho HK, Chew L, Tan TJ. HEalth-Related Quality of Life-Intervention in Survivors of Breast and Other Cancers Experiencing Cancer-Related Fatigue and Associated Cognitive Symptoms Using TraditionAL Chinese Medicine: The 'HERBAL' Trial. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251314514. doi: 10.1177/15347354251314514.

    PMID: 39840742DERIVED

  • Yap NY, Loo WS, Zheng HF, Tan QM, Tan TK, Quek LYP, Tan CJ, Toh YL, Ng CC, Ang SK, Tan VKM, Ho HK, Chew L, Loh KW, Tan TJY, Chan A. 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. 2020 Nov 4;21(1):909. doi: 10.1186/s13063-020-04810-4.

    PMID: 33187543DERIVED

MeSH Terms

Conditions

NeoplasmsFatigueCognitive Dysfunction

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Alexandre Chan, Pharm D

    National University of Singapore, National Cancer Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Chan, Pharm D

CONTACT

6516 2648alexandre.chan@nccs.com.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr. Alexandre Chan

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

October 24, 2019

Primary Completion

May 30, 2021

Study Completion

June 9, 2022

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)