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

June 13, 2020 updated by: Alexandre Chan, National University, Singapore

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥21 years
  2. Clinically diagnosed cancer (Stages I-III)
  3. Completed surgery/chemotherapy/radiotherapy for at least 1 month
  4. At least one month after starting on aromatase inhibitors or ovarian suppression for breast cancer survivors
  5. Not expected to receive surgery/chemotherapy/radiotherapy next 10 weeks
  6. Fatigue screening score ≥4 for past 7 days
  7. Life expectancy ≥3 months
  8. 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
  9. Able to read and understand English or Mandarin

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: XBYRT decoction
Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules
Other: Modified Xiang Bei Yang Rong Tang
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
PLACEBO_COMPARATOR: Placebo
Participants assigned to receive placebo (contains 5% of XBYRT) granules
Other: Placebo
Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Global Health Status (GHS) score
Time Frame: 8 weeks from baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores
Time Frame: 4, 8 and 10 weeks from baseline
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)
4, 8 and 10 weeks from baseline
Difference in Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 scores
Time Frame: 4, 8 and 10 weeks from baseline
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.
4, 8 and 10 weeks from baseline
Incidence of adverse events
Time Frame: baseline, and 4, 8 and 10 weeks from baseline
Adverse events reported according to the Adverse events Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
baseline, and 4, 8 and 10 weeks from baseline
Difference in EORTC QLQ-C30 version 3.0 Functional and Symptom scale scores
Time Frame: 4, 8 and 10 weeks from baseline
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.
4, 8 and 10 weeks from baseline
Mitochondrial DNA (mtDNA) content
Time Frame: baseline, 4, 8 and 10 weeks from baseline
Mitochondrial DNA (mtDNA) content reduction in XBYRT interventional and placebo arms
baseline, 4, 8 and 10 weeks from baseline
Inflammatory cytokines : C reactive protein (CRP) and cytokines TNF-α, IL-1β, IL-6, and IL-8
Time Frame: baseline, 4, 8 and 10 weeks from baseline
Plasma inflammatory cytokine levels in XBYRT interventional and placebo arms
baseline, 4, 8 and 10 weeks from baseline
Oxidative stress markers : malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px)
Time Frame: baseline, 4, 8 and 10 weeks from baseline
Plasma oxidative stress markers levels in XBYRT interventional and placebo arms
baseline, 4, 8 and 10 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

National Cancer Centre, Singapore
Singapore Thong Chai Medical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 24, 2019

Primary Completion (ANTICIPATED)

May 30, 2021

Study Completion (ANTICIPATED)

June 9, 2022

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref. No: 2019/2135
  • TCMRG-3-NUS-01 (OTHER_GRANT: Ministry of Health Traditional Chinese Medicine Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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