Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Fatigue
Cognitive Impairment
Keywords: Cancer
Cancer Related Fatigue
Cognitive Impairment
Survivorship
Traditional Chinese Medicine
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Cancer Centre, Singapore
name: Singapore Thong Chai Medical Institute
First posted: 2019-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 alleviating cancer related fatigue in cancer survivors.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference in Global Health Status (GHS) score
timeFrame: 8 weeks from baseline
Secondary outcomes:
measure: Difference in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores
timeFrame: 4, 8 and 10 weeks from baseline
measure: Difference in Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 scores
timeFrame: 4, 8 and 10 weeks from baseline
measure: Incidence of adverse events
timeFrame: baseline, and 4, 8 and 10 weeks from baseline
measure: Difference in EORTC QLQ-C30 version 3.0 Functional and Symptom scale scores
timeFrame: 4, 8 and 10 weeks from baseline
measure: Mitochondrial DNA (mtDNA) content
timeFrame: baseline, 4, 8 and 10 weeks from baseline
measure: Inflammatory cytokines : C reactive protein (CRP) and cytokines TNF-α, IL-1β, IL-6, and IL-8
timeFrame: baseline, 4, 8 and 10 weeks from baseline
measure: Oxidative stress markers : malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px)
timeFrame: baseline, 4, 8 and 10 weeks from baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National University of Singapore, National Cancer Centre Singapore
name: Alexandre Chan, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yap 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.