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

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

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Lung Cancer; Colon Cancer
• Intervention / Treatment: Other: Placebo; Dietary supplement: Somnage

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)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Istituto Nazionale dei Tumori di Milano
  • Milan, Italy, 20141
    • I.E.O. Istituto Europeo di Oncologia
  • Monza, Italy, 20052
    • Azienda Ospedaliera S. Gerardo di Monza
  • Pavia, Italy, 27100
    • Policlinico S. Matteo di Pavia
  • Pavia, Italy
    • Azienda di Servizi alla Persona di Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somnage; Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.	Dietary supplement: Somnage; Melatonin 1mg, Zinc, Magnesium
Placebo Comparator: Placebo; Oral administration o.d.	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinn Healthcare SA

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: HF02-13-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO