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

Trial number:
NCT04104113
Trial phase:
2
Study type:
Supportive interventions
Overall status:
Recruiting

Study start date

October, 2019

Scientific 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

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.

Age ≥21 yearsClinically 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

Cancer recurrence and/or metastasisUntreated 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)

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Quadruple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes, Outcomes assessor masked: Yes,

Conditions

Cancer, Fatigue, Cognitive Impairment

Other study ID numbers

CIRB Ref. No: 2019/2135; TCMRG-3-NUS-01

Choose trial site (2)

National Cancer Centre Singapore
National Cancer Centre Singapore Completed
11 Hospital Dr, Singapore 169610