Last updated on August 2016

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


Brief description of study

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 Study 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)

Clinical Study Identifier: NCT02883790

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Plantanida Marco, MD

Istituto Nazionale dei Tumori di Milano
Milan, Italy
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Locatelli Marzia Adelia, MD

I.E.O. Istituto Europeo di Oncologia
Milan, Italy
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Cortinovis Diego, MD

Azienda Ospedaliera S. Gerardo di Monza
Monza, Italy
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Pedrazzoli Paolo, MD

Policlinico S. Matteo di Pavia
Pavia, Italy
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Rondanelli Mariangela, Prof. MD.

Azienda di Servizi alla Persona di Pavia
Pavia, Italy
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