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

Primary Purpose

Breast Cancer, Lung Cancer, Colon Cancer

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Somnage
Placebo
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istituto Nazionale dei Tumori di Milano
  • I.E.O. Istituto Europeo di Oncologia
  • Azienda Ospedaliera S. Gerardo di Monza
  • Policlinico S. Matteo di Pavia
  • Azienda di Servizi alla Persona di Pavia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Somnage

Placebo

Arm Description

Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.

Oral administration o.d.

Outcomes

Primary Outcome Measures

Quality of sleep assessed using the PSQI scale
PSQI scale

Secondary Outcome Measures

Subjective sleep quality through sleep diary
Sleep diary analysis
Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
Fatigue assessment through Brief Fatigue Inventory (BFI) questionnaire
Quality of Life evaluated according to SF-12 scale
Quality of Life evaluated according to SF-12 scale

Full Information

First Posted
January 26, 2016
Last Updated
February 20, 2019
Sponsor
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT02883790
Brief Title
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Low enrolment rate
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Colon Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somnage
Arm Type
Experimental
Arm Description
Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration o.d.
Intervention Type
Dietary Supplement
Intervention Name(s)
Somnage
Intervention Description
Melatonin 1mg, Zinc, Magnesium
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Quality of sleep assessed using the PSQI scale
Description
PSQI scale
Time Frame
up to 63 days of treatment
Secondary Outcome Measure Information:
Title
Subjective sleep quality through sleep diary
Description
Sleep diary analysis
Time Frame
up to 63 days of treatment
Title
Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
Description
Fatigue assessment through Brief Fatigue Inventory (BFI) questionnaire
Time Frame
up to 63 days of treatment
Title
Quality of Life evaluated according to SF-12 scale
Description
Quality of Life evaluated according to SF-12 scale
Time Frame
up to 63 days of treatment
Other Pre-specified Outcome Measures:
Title
Number and typology of adverse events
Description
Number and typology of adverse events (AEs), Physical examination, Vital signs, Laboratory tests (hematology, blood chemistry)
Time Frame
up to 63 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and Females aged between 18 and 75 years (included) Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 Diagnosed for breast, lung or colon-rectal cancer Metastatic first chemotherapy line Planned duration of chemotherapy treatment at least 63 days Negative to pregnancy test Patients able to swallow Exclusion Criteria: Known hypersensitivity reaction to Melatonin, Zinc or Magnesium or any components of the product Known current drug or alcohol abuse. Use of other investigational drug(s) within 30 days before study entry or during the study Clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation Patients treated with benzodiazepines, hypnotic, anticonvulsant, antipsychotic or antidepressant drugs in the two months before screening visit Patients receiving or planned to receive warfarin Chronic treatment with steroids with daily dose over 10 mg prednisone or equivalent product Brain metastases
Facility Information:
Facility Name
Istituto Nazionale dei Tumori di Milano
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
I.E.O. Istituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera S. Gerardo di Monza
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Policlinico S. Matteo di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda di Servizi alla Persona di Pavia
City
Pavia
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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