Clinical trial · Interventional
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
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
NCT02883790CI-TRIAL-00037221terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrolment rate
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Somnage | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Somnage
- description
- Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.
- interventionNames
- Dietary Supplement: Somnage
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Oral administration o.d.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Quality of sleep assessed using the PSQI scale
- timeFrame
- up to 63 days of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.