NCT02883790

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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)

Conditions

• Breast Cancer
• Lung Cancer
• Colon Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Somnage	Melatonin 1mg, Zinc, Magnesium
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-08-30
• Last updated: 2019-02-22

Locations

5 sites across 1 country: Italy