A Pragmatic Randomised, Multicentre Trial Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance (REaCT-CHRONO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Change in Endocrine Toxicity and Tolerability at 12 Weeks
研究概览
简要总结
Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.
详细描述
Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Compliance is defined as the degree or extent of conformity to the recommended administration by the provider, whereas persistence refers to the act of continuing treatment for a certain prescribed duration. Treatment adherence is especially important in breast cancer, as early cessation or reduced compliance to hormonal therapy are associated with reduced disease-free survival and increased mortality. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an early stage or locally advanced hormonal receptor positive breast cancer
- •Plan to receive endocrine therapy
- •18 years of age or older
- •Able to provide oral consent
- •Willing and able to complete questionnaires as per study protocol
排除标准
- •Metastatic cancer
- •Previous endocrine therapy for breast cancer
- •Plan to receive adjuvant abemaciclib
研究组 & 干预措施
Morning administration of endocrine therapy
Administration of endocrine therapy defined as, within one hour of the patient wake up time
干预措施: Morning administration of endocrine therapy (Other)
Evening administration of endocrine therapy
Administration of endocrine therapy defined as, within one hour of the patient bed time
干预措施: Evening administration of endocrine therapy (Other)
结局指标
主要结局
Change in Endocrine Toxicity and Tolerability at 12 Weeks
时间窗: Baseline to 12 weeks after treatment initiation
Measured by the change in total Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire from baseline to 12 weeks following the beginning of endocrine therapy. FACT-ES is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much), with a total range of 0 to 184. Higher FACT-ES scores indicate better outcomes. The current outcome is a change in FACT-ES scores.
次要结局
- Change in Endocrine Toxicity and Tolerability(Baseline, 4, 8, 12 and 52 weeks after treatment initiation)
- Change in Health Related Quality of Life Scores(Baseline, 4, 8, 12 and 52 weeks after treatment initiation)
- Number of Participants Who Were Compliant With ET(52 weeks after treatment initiation)
- Cost-effectiveness(52 weeks after treatment initiation)