Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled, Study to Evaluate the Effects of Melatonin (Somnage®- Food Supplement) in the Management on Sleep Quality and Mood Alteration in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 9
- 主要终点
- Quality of sleep assessed using the PSQI scale
研究概览
简要总结
The aim of this placebo-controlled randomized study is to evaluate the effects of Melatonin 1mg/Zn 30% VNR/Mg 100% VNR (food supplement) in the management on sleep quality and mood alteration in cancer patients
详细描述
The main objective of this study is to evaluate the activity of a food supplement, made of Melatonin, Zinc and Magnesium on sleep quality in cancer patients, compared to placebo.
Secondary objectives are to evaluate the activity of Melatonin, Zinc and Magnesium on the quality of life, on the fatigue and on the mood alteration in cancer patients.
The study will also assess the safety of the food supplement under investigation.
In two small subgroups, on voluntary basis, some additional assessments will be done (arm band, nutritional change diary, DXA in one group and activity tracker in another group)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Females aged between 18 and 75 years (included)
- •Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
- •Diagnosed for breast, lung or colon-rectal cancer
- •Metastatic first chemotherapy line
- •Planned duration of chemotherapy treatment at least 63 days
- •Negative to pregnancy test
- •Patients able to swallow
排除标准
- •Known hypersensitivity reaction to Melatonin, Zinc or Magnesium or any components of the product
- •Known current drug or alcohol abuse.
- •Use of other investigational drug(s) within 30 days before study entry or during the study
- •Clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation
- •Patients treated with benzodiazepines, hypnotic, anticonvulsant, antipsychotic or antidepressant drugs in the two months before screening visit
- •Patients receiving or planned to receive warfarin
- •Chronic treatment with steroids with daily dose over 10 mg prednisone or equivalent product
- •Brain metastases
研究组 & 干预措施
Somnage
Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.
干预措施: Somnage (Dietary Supplement)
Placebo
Oral administration o.d.
干预措施: Placebo (Other)
结局指标
主要结局
Quality of sleep assessed using the PSQI scale
时间窗: up to 63 days of treatment
PSQI scale
次要结局
- Subjective sleep quality through sleep diary(up to 63 days of treatment)
- Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire(up to 63 days of treatment)
- Quality of Life evaluated according to SF-12 scale(up to 63 days of treatment)