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

National University of Singapore

Status and phase: Unknown; Phase 2

Conditions: Cognitive Impairment; Cancer; Fatigue

Treatments: Other: Modified Xiang Bei Yang Rong Tang; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04104113

CIRB Ref. No: 2019/2135

TCMRG-3-NUS-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 conventional pharmacological intervention for treating this condition. Traditional Chinese Medicine (TCM) could be alternative therapy for managing CRF.

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

XBYRT decoction

Experimental group

Description:

Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules

Treatment:

Other: Modified Xiang Bei Yang Rong Tang

Placebo

Placebo Comparator group

Description:

Participants assigned to receive placebo (contains 5% of XBYRT) granules

Treatment:

Other: Placebo