Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
NCT ID: NCT02883790
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2015-10-31
2018-02-28
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Somnage
Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d.
Somnage
Melatonin 1mg, Zinc, Magnesium
Placebo
Oral administration o.d.
Placebo
Placebo
Interventions
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Somnage
Melatonin 1mg, Zinc, Magnesium
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
Yes
Sponsors
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Helsinn Healthcare SA
INDUSTRY
Responsible Party
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Locations
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Istituto Nazionale dei Tumori di Milano
Milan, , Italy
I.E.O. Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera S. Gerardo di Monza
Monza, , Italy
Policlinico S. Matteo di Pavia
Pavia, , Italy
Azienda di Servizi alla Persona di Pavia
Pavia, , Italy
Countries
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Other Identifiers
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HF02-13-42
Identifier Type: -
Identifier Source: org_study_id
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