HEalth-Related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using TraditionAL Chinese Medicine: The HERBAL Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in Global Health Status (GHS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Difference in Global Health Status (GHS) score
时间窗: 8 weeks from baseline
Difference in Global Health Status (GHS) score from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between XBYRT interventional and placebo arms from baseline to 8 weeks after baseline. The GHS scale ranges in score from 0-100. A higher score represents a better quality of life
次要结局
- Difference in Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 scores(4, 8 and 10 weeks from baseline)
- Incidence of adverse events(baseline, and 4, 8 and 10 weeks from baseline)
- Oxidative stress markers : malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px)(baseline, 4, 8 and 10 weeks from baseline)
- Difference in EORTC QLQ-C30 version 3.0 Functional and Symptom scale scores(4, 8 and 10 weeks from baseline)
- Difference in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) scores(4, 8 and 10 weeks from baseline)
- Mitochondrial DNA (mtDNA) content(baseline, 4, 8 and 10 weeks from baseline)
- Inflammatory cytokines : C reactive protein (CRP) and cytokines TNF-α, IL-1β, IL-6, and IL-8(baseline, 4, 8 and 10 weeks from baseline)
研究者
Alexandre Chan
Associate Professor Dr. Alexandre Chan
National Cancer Centre, Singapore