Clinical trial · Interventional
Health-related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using Traditional Chinese Medicine: The HERBAL Trial
HEalth-Related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using TraditionAL Chinese Medicine: The HERBAL Trial
NCT04104113CI-TRIAL-00045539HERBALunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cognitive Impairment | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified Xiang Bei Yang Rong Tang | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- XBYRT decoction
- description
- Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules
- interventionNames
- Other: Modified Xiang Bei Yang Rong Tang
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants assigned to receive placebo (contains 5% of XBYRT) granules
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Difference in Global Health Status (GHS) score
- timeFrame
- 8 weeks from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDChan 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 39840742
- DERIVEDYap 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 33187543