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

Not Applicable

Terminated

• Conditions: Breast Cancer; Lung Cancer; Colon Cancer
• Interventions: Other: Placebo; Dietary Supplement: Somnage

• Registration Number: NCT02883790
• Lead Sponsor: Helsinn Healthcare SA

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)

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-26
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral administration o.d.
Somnage	Somnage	Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.

Primary Outcome Measures

Name	Time	Method
Quality of sleep assessed using the PSQI scale	up to 63 days of treatment	PSQI scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Istituto Nazionale dei Tumori di Milano; 🇮🇹 Milan, Italy

I.E.O. Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy

Policlinico S. Matteo di Pavia; 🇮🇹 Pavia, Italy

Azienda Ospedaliera S. Gerardo di Monza; 🇮🇹 Monza, Italy

Azienda di Servizi alla Persona di Pavia; 🇮🇹 Pavia, Italy