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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Helsinn Healthcare SA
- Enrollment
- 3
- Locations
- 5
- Primary Endpoint
- Quality of sleep assessed using the PSQI scale
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Quality of sleep assessed using the PSQI scale
Time Frame: up to 63 days of treatment
PSQI scale
Secondary Outcomes
- 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)