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

Helsinn Healthcare

Status: Terminated

Conditions: Breast Cancer; Colon Cancer; Lung Cancer

Treatments: Other: Placebo; Dietary Supplement: Somnage

Study type: Interventional

Funder types: Industry

Identifiers

NCT02883790

HF02-13-42

Details and patient eligibility

About

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

Full 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)

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Somnage

Experimental group

Description:

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

Treatment:

Dietary Supplement: Somnage

Placebo

Placebo Comparator group

Description:

Oral administration o.d.

Treatment:

Other: Placebo