/NCT04104113

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

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 (1)

National Cancer Centre Singapore

11 Hospital Cres, Singapore 169610