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

NCT02883790 | Terminated

• 1 other identifier: HF02-13-42
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

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

Conditions

Breast Cancer; Lung Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of sleep assessed using the PSQI scale

  PSQI scale

  up to 63 days of treatment

Secondary Outcomes (3)

• Subjective sleep quality through sleep diary

  up to 63 days of treatment

• Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire

  up to 63 days of treatment

• Quality of Life evaluated according to SF-12 scale

  up to 63 days of treatment

Other Outcomes (1)

• Number and typology of adverse events

  up to 63 days of treatment

Study Arms (2)

Somnage

EXPERIMENTAL

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

Dietary Supplement: Somnage

Placebo

PLACEBO COMPARATOR

Oral administration o.d.

Other: Placebo

Interventions

Somnage DIETARY_SUPPLEMENT

Melatonin 1mg, Zinc, Magnesium

Somnage

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (5)

Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

Location

I.E.O. Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera S. Gerardo di Monza

Monza, 20052, Italy

Location

Policlinico S. Matteo di Pavia

Pavia, 27100, Italy

Location

Azienda di Servizi alla Persona di Pavia

Pavia, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: August 30, 2016
• Study Start: October 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)