Breast CancerNCT02883790
Effects of Somnage® in the Management on Sleep and Mood in Cancer Patients
A study testing Somnage in people with Breast Cancer and Lung Cancer, run by Helsinn Healthcare SA at 5 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colon Cancer
- What is being tested?
- Somnage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 5 sitesItaly
- Study dates
- Oct 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Istituto Nazionale dei Tumori di Milano
Milan, 20133
I.E.O. Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliera S. Gerardo di Monza
Monza, 20052
Policlinico S. Matteo di Pavia
Pavia, 27100
Azienda di Servizi alla Persona di Pavia
Pavia
About this study
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
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
Read the 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)
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer
- Being tested
- Somnage, Placebo
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomnageDietary supplement
Melatonin 1mg, Zinc, Magnesium
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Somnage | Experimental | Group A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d. Receives: Dietary Supplement: Somnage |
| Placebo | Placebo comparator | Oral administration o.d. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep assessed using the PSQI scale
PSQI scale
Measured: up to 63 days of treatment
Secondary outcomes (3)
Subjective sleep quality through sleep diary
Sleep diary analysis
Measured: up to 63 days of treatment
Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
Fatigue assessment through Brief Fatigue Inventory (BFI) questionnaire
Measured: up to 63 days of treatment
Quality of Life evaluated according to SF-12 scale
Quality of Life evaluated according to SF-12 scale
Measured: up to 63 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Low enrolment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883790
- Sponsor's protocol ID
- HF02-13-42
- Status last verified
- Aug 2016
- First submitted
- 26 Jan 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02883790
- Acronym / sponsor ID
- HF02-13-42
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrolment rate
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somnage | Experimental | Dietary Supplement: SomnageGroup A-Melatonin 1mg, Zinc, Magnesium Oral administration o.d. |
| Placebo | Placebo comparator | Other: PlaceboOral administration o.d. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomnageMelatonin 1mg, Zinc, Magnesium | Dietary supplement | Somnage |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Quality of sleep assessed using the PSQI scale
Time frame: up to 63 days of treatment
PSQI scale
3 secondary outcomes
Subjective sleep quality through sleep diary
Time frame: up to 63 days of treatment
Overall fatigue assessed using the Brief Fatigue Inventory (BFI) questionnaire
Time frame: up to 63 days of treatment
Quality of Life evaluated according to SF-12 scale
Time frame: up to 63 days of treatment
Results and safety
The study was stopped early (reason given: Low enrolment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnage in people with Breast Cancer and Lung Cancer, run by Helsinn Healthcare SA at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrolment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep assessed using the PSQI scale (time frame: up to 63 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.