Clinical trial NCT02883790: 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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Colon Cancer
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Quality of sleep assessed using the PSQI scale
timeFrame: up to 63 days of treatment
Secondary outcomes:
measure: Subjective sleep quality through sleep diary
timeFrame: up to 63 days of treatment
measure: Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
timeFrame: up to 63 days of treatment
measure: Quality of Life evaluated according to SF-12 scale
timeFrame: up to 63 days of treatment
Other outcomes:
measure: Number and typology of adverse events
timeFrame: up to 63 days of treatment
Locations:
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori di Milano
city: Milan
country: Italy
facility: I.E.O. Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo di Monza
city: Pavia
country: Italy
facility: Policlinico S. Matteo di Pavia
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona di Pavia
Study officials:
References: