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CancerPhase 2HERBALNCT04104113

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

A Phase 2 study testing Modified Xiang Bei Yang Rong Tang in people with Cancer and Fatigue, run by National University of Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Cancer, Fatigue, Cognitive Impairment
What is being tested?
Modified Xiang Bei Yang Rong Tang
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSingapore
Study dates
24 Oct 2019to 9 Jun 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Alexandre Chan, Pharm D contact

6516 2648

alexandre.chan@nccs.com.sg

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore

    Singapore, 169610

    Alexandre Chan, PharmD, alexandre.chan@nccs.com.sg

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the detailed description

Cancer-related fatigue (CRF) is a distressing, persistent and subjective sense of physical, emotional, or cognitive tiredness related to cancer or its treatment. Currently there is a lack of effective conventional pharmacological intervention for treating this condition. Traditional Chinese Medicine (TCM) could be alternative therapy for managing CRF.

This study is a phase 2, randomized, double-blinded, placebo-controlled trial to examine the efficacy and safety of a TCM decoction, the modified Xiang Bei Yang Rong Tang (XBYRT) in alleviating CRF in cancer survivors. Study participants recruited from National Cancer Centre Singapore (NCCS) will be randomized to receive either the XBYRT or placebo decoction. Participants will take their assigned decoction daily for a duration of 8 weeks and will be assessed using patient reported outcome (PRO) questionnaires. PROs used are the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ 30) for QOL, the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) for fatigue and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Version 3 for cognitive abilities. The changes in scores measured by these assessment tools will be compared between the XBYRT intervention and placebo groups. Blood biomarkers such as inflammatory cytokines, mitochondrial DNA and oxidative stress markers will also be evaluated in the study participants. Additionally, adverse events or serious adverse events in participants will be monitored for safety.

Results from this study will provide a better understanding on the role of TCM in managing CRF.

Being tested
Modified Xiang Bei Yang Rong Tang, Placebo
Keywords
Cancer, Cancer Related Fatigue, Cognitive Impairment, Survivorship, Traditional Chinese Medicine
Medical subject headings
Neoplasms, Fatigue, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • PlaceboOther

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

Study groups in NCT04104113
Study groupRoleWhat they receive
XBYRT decoctionExperimentalParticipants assigned to receive the modifed Xiang Bei Yang Rong Tang granules
Receives: Other: Modified Xiang Bei Yang Rong Tang
PlaceboPlacebo comparatorParticipants assigned to receive placebo (contains 5% of XBYRT) granules
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 weeks from baseline

Secondary outcomes (7)

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

    Difference in MFSI-SF scores between XBYRT interventional and placebo arms. THE MFSI-SF consists of 30 items and has 5 subscales, each with 6 items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigour. The MFSI-SF measures different dimensions of fatigue, which can be combined to obtain an overall score. A higher score represents worse fatigue (total score ranges from -24 to 96)

    Measured: 4, 8 and 10 weeks from baseline

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

    Difference in FACT-Cog V3 scores between XBYRT interventional and placebo arms. FACT-Cog v.3 will be used to assess subjective cognitive disturbances. These disturbances are assessed via 33 items in the domains of concentration, functional interference, mental acuity, memory, multitasking and verbal fluency (total score ranges from 0-148). A lower score represents worse cognitive function.

    Measured: 4, 8 and 10 weeks from baseline

  3. Incidence of adverse events

    Adverse events reported according to the Adverse events Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: baseline, and 4, 8 and 10 weeks from baseline

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

    Difference in EORTC QLQ-C30 scores between XBYRT interventional and placebo arms. The EORTC QLQ-C30 consists of 30 items across functional domains, symptoms domains and a global health status domain. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of problems.

    Measured: 4, 8 and 10 weeks from baseline

  5. Mitochondrial DNA (mtDNA) content

    Mitochondrial DNA (mtDNA) content reduction in XBYRT interventional and placebo arms

    Measured: baseline, 4, 8 and 10 weeks from baseline

  6. Inflammatory cytokines : C reactive protein (CRP) and cytokines TNF-α, IL-1β, IL-6, and IL-8

    Plasma inflammatory cytokine levels in XBYRT interventional and placebo arms

    Measured: baseline, 4, 8 and 10 weeks from baseline

  7. Oxidative stress markers : malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px)

    Plasma oxidative stress markers levels in XBYRT interventional and placebo arms

    Measured: baseline, 4, 8 and 10 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start24 Oct 2019
  3. Primary completion30 May 2021 (estimated)
  4. Study completion9 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04104113
Sponsor's protocol ID
CIRB Ref. No: 2019/2135
Other IDs
TCMRG-3-NUS-01
Acronym
HERBAL
Status last verified
Jun 2020
First submitted
24 Sep 2019
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39840742

  • 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.

    PubMed 33187543

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modified Xiang Bei Yang Rong Tang in people with Cancer and Fatigue, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexandre Chan, Pharm D (6516 2648, alexandre.chan@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Global Health Status (GHS) score (time frame: 8 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104113, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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