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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02883790
• Other study ID #: HF02-13-42
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2018

Study information

• Verified date: August 2016
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Lung Cancer

Intervention

Dietary Supplement:
• Somnage
Melatonin 1mg, Zinc, Magnesium

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	I.E.O. Istituto Europeo di Oncologia	Milan
Italy	Istituto Nazionale dei Tumori di Milano	Milan
Italy	Azienda Ospedaliera S. Gerardo di Monza	Monza
Italy	Azienda di Servizi alla Persona di Pavia	Pavia
Italy	Policlinico S. Matteo di Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Healthcare SA

Country where clinical trial is conducted

Italy, 

Outcome

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