Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 12
- 主要终点
- comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
研究概览
简要总结
Melatonin may represent an effective complementary treatment to standard anticancer treatments in order to reduce asthenia, depression, sleep disturbances, cognitive impairment and performance status as part of quality of life. Moreover, melatonin has been evaluated in several clinical trials in cancer patients with no side effects. It could be particularly of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin production .
The investigators propose to perform a prospective and randomized study to study the effect of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer patients (age ≥ 70) treated for a locally advanced or metastatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > = 70 years.
- •Performance status < = 2 (WHO criteria)
- •Life expectancy > 3months
- •A patient with solid tumor locally advanced or metastatic
- •Indication of systemic anticancer treatment : oral or IV chemotherapy, endocrine therapy, target therapy or immunotherapy
- •MMS-orientation ≥ 7 (geriatric Mini Mental State face-to-face questionnaire)
- •Able to swallow and retain oral treatment
- •Patient who signed the participation consent before entering the trial
- •Patient able to read, write and understand French.
- •Affiliation to the french social security scheme (or beneficiary of such a scheme) under the terms of the law of 9 August 2004.
排除标准
- •Haematological cancers
- •Renal failure or hepatic failure
- •Auto-immune disease
- •Diagnosed neurodegenerative diseases
- •Unability to fill out questionnaires
- •melatonin treatment ongoing or completed for less than 3 months
- •Treatment with an investigational drug, participation to another therapeutic clinical trial within <30 days
- •Hypersensitivity to melatonin or any of the excipients
- •Current Treatment with fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, estrogen
- •A history of known or suspected excessive alcohol use.
- •Patient refusing to participate and / or unable to give informed consent
- •Patient unable to complete the questionnaires even with the help of a relative or a nurse
- •Patient does not have the capacity to comply with the study requirements
- •Patient deprived of liberty by a court or administrative.
研究组 & 干预措施
Group "Melatonin"
standard anticancer treatment + 3-month of melatonin supplementation
干预措施: melatonin (Drug)
Group "Placebo"
standard anticancer treatment + placebo (3 months)
干预措施: placebo (Drug)
结局指标
主要结局
comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
时间窗: 3 months
The quality of life will be assessed using the QLQ-C30 questionnaire. the change in absolute value (inclusion versus after 3 months of supplementation) of overall score of QLQ-C30.
次要结局
- Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"(1 year)
- longitudinal evolution of QLQ-C30 scores(1 year)
- Evolution of scores of QLQ-ELD14(1 year)
- sleep quality: Questionnaire Leeds(1 year)
- Fatigue: visual analog scale (VAS)(1 year)
- Pain: VAS(1 year)
- Depression: Questionnaire GDS (Geriatric Depression Scale)(1 year)
- Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0(1 year)
- one year Overall survival rate(1 year)
- one year recurrence-free survival rate(1 year)
- Cognitive function: MMS (mini-mental score) or Folstein test(1 year)
- Evaluation of autonomy: ADL-IADL questionnaires(1 year)
- Compliance to treatment(3 months)
- evaluation of the appetite with an EVA(1 year)
- evaluation of Dietary intake with dietary questionnaires(1 year)
- Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria(3 months)
- Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours(baseline and after 3 months of treatment)