Breast CancerNCT01611038
Methylselenocysteine Effects on Circadian Rhythm
A study testing Methylselenocysteine in people with Breast Cancer and Prostate Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Methylselenocysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2015
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent night shift schedule
Who cannot join
- Nutritional supplements that contain selenium
- Pregnant
- Breast feeding
- Heart conditions
- Chronic lung disease
- Cancer therapy (current or past)
Trial locations and contacts
1 site in 1 country.
United States1 site
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, 08854
About this study
Official title: Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling
The primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.
Read the detailed description
All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Methylselenocysteine, Placebo
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylselenocysteineDietary supplement
Methylselenocysteine capsule given daily
PlaceboDietary supplement
Placebo capsule given daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo given daily Receives: Dietary Supplement: Placebo |
| Methylselenocysteine | Experimental | Methylselenocysteine given daily Receives: Dietary Supplement: Methylselenocysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJun 2015
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.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Howard M. Kipen, MD, MPH, Principal investigator, Rutgers, The State University of New JerseyHelmut Zarbl, MD, Study chair, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611038
- Sponsor's protocol ID
- 0220100243
- Status last verified
- Sep 2017
- First submitted
- 18 May 2012
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoprevention of Breast and Prostate Cancers in Shift Workers by Dietary Methylselenocysteine: Effects on Circadian Rhythm and Estrogen Receptor-B Cycling
- ClinicalTrials.gov ID
- NCT01611038
- Acronym / sponsor ID
- 0220100243
- Conditions
- Breast Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jun 2012 (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 primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.
Detailed description
All living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. The circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. This suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. Studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. Other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo given daily |
| Methylselenocysteine | Experimental | Dietary Supplement: MethylselenocysteineMethylselenocysteine given daily |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Permanent night shift schedule
Key exclusion criteria (6 listed)
- Nutritional supplements that contain selenium
- Pregnant
- Breast feeding
- Heart conditions
- Chronic lung disease
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 |
|---|---|---|
| MethylselenocysteineMethylselenocysteine capsule given daily | Dietary supplement | Methylselenocysteine |
| PlaceboPlacebo capsule given daily | Dietary supplement | Placebo |
Primary outcome
Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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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.
Howard M. Kipen, MD, MPH principal investigator
Rutgers, The State University of New Jersey
Helmut Zarbl, MD study chair
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylselenocysteine in people with Breast Cancer and Prostate Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine if selenium (i.e., methylselenocysteine) supplementation can restore disruption of circadian rhythm and estrogen receptor-B levels in shift workers (time frame: 30 days). 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 12 Sep 2017.