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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02883790

Enrollment

Registered

2016-08-30

Start date

2015-10-31

Completion date

2018-02-28

Last updated

2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colon Cancer, Lung Cancer

Brief 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)

Interventions

DIETARY_SUPPLEMENTSomnage

Melatonin 1mg, Zinc, Magnesium

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male and Females aged between 18 and 75 years (included) 2. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 3. Diagnosed for breast, lung or colon-rectal cancer 4. Metastatic first chemotherapy line 5. Planned duration of chemotherapy treatment at least 63 days 6. Negative to pregnancy test 7. Patients able to swallow

Exclusion criteria

1. Known hypersensitivity reaction to Melatonin, Zinc or Magnesium or any components of the product 2. Known current drug or alcohol abuse. 3. Use of other investigational drug(s) within 30 days before study entry or during the study 4. Clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation 5. Patients treated with benzodiazepines, hypnotic, anticonvulsant, antipsychotic or antidepressant drugs in the two months before screening visit 6. Patients receiving or planned to receive warfarin 7. Chronic treatment with steroids with daily dose over 10 mg prednisone or equivalent product 8. Brain metastases

Design outcomes

Primary

Measure	Time frame	Description
Quality of sleep assessed using the PSQI scale	up to 63 days of treatment	PSQI scale

Secondary

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

Other

Measure	Time frame	Description
Number and typology of adverse events	up to 63 days of treatment	Number and typology of adverse events (AEs), Physical examination, Vital signs, Laboratory tests (hematology, blood chemistry)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026