Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Breast Cancer, Lung Cancer, Colon Cancer

Intervention / Treatment
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* Dietary Supplement: Somnage
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somnage<br>Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d. | Dietary Supplement: Somnage<br>* Melatonin 1mg, Zinc, Magnesium<br>|
| Placebo Comparator: Placebo<br>Oral administration o.d. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep assessed using the PSQI scale | PSQI scale | up to 63 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality through sleep diary | Sleep diary analysis | up to 63 days of treatment | 
| Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire | Fatigue assessment through Brief Fatigue Inventory (BFI) questionnaire | up to 63 days of treatment | 
| Quality of Life evaluated according to SF-12 scale | Quality of Life evaluated according to SF-12 scale | up to 63 days of treatment |