Breast Cancer Clinical Trial
Official title:
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
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
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)
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