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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
3
Istituto Nazionale dei Tumori di Milano
Milan, Italy
I.E.O. Istituto Europeo di Oncologia
Milan, Italy
Azienda Ospedaliera S. Gerardo di Monza
Monza, Italy
Policlinico S. Matteo di Pavia
Pavia, Italy
Quality of sleep assessed using the PSQI scale
PSQI scale
Time frame: up to 63 days of treatment
Subjective sleep quality through sleep diary
Sleep diary analysis
Time frame: up to 63 days of treatment
Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
Fatigue assessment through Brief Fatigue Inventory (BFI) questionnaire
Time frame: up to 63 days of treatment
Quality of Life evaluated according to SF-12 scale
Quality of Life evaluated according to SF-12 scale
Time frame: up to 63 days of treatment
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Azienda di Servizi alla Persona di Pavia
Pavia, Italy