Status:
UNKNOWN
Health-related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using Traditional Chinese Medicine: The HERBAL Trial
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
National Cancer Centre, Singapore
Singapore Thong Chai Medical Institute
Conditions:
Cancer
Fatigue
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 9 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04104113
Start Date
October 24 2019
End Date
June 9 2022
Last Update
June 16 2020
Active Locations (1)
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1
National Cancer Centre Singapore
Singapore, Singapore, 169610