Health-related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using Traditional Chinese Medicine: The HERBAL Trial
NCT ID: NCT04104113
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2019-10-24
2022-06-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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XBYRT decoction
Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules
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
Participants assigned to receive placebo (contains 5% of XBYRT) granules
Placebo
Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler
Interventions
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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
Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler
Eligibility Criteria
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Inclusion Criteria
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
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)
21 Years
80 Years
ALL
No
Sponsors
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National Cancer Centre, Singapore
OTHER
Singapore Thong Chai Medical Institute
UNKNOWN
National University of Singapore
OTHER
Responsible Party
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Alexandre Chan
Associate Professor Dr. Alexandre Chan
Principal Investigators
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Alexandre Chan, Pharm D
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore, National Cancer Centre Singapore
Locations
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National Cancer Centre Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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TCMRG-3-NUS-01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIRB Ref. No: 2019/2135
Identifier Type: -
Identifier Source: org_study_id
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