Breast CancerEarly Phase 1NCT01805089
Melatonin Versus Placebo in Breast Cancer
A Early Phase 1 study testing Melatonin 3 mg in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Melatonin 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Jul 2009
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer
- Not currently receiving chemotherapy or hormonal therapy
- Postmenopausal
Who cannot join
- Stage IV breast cancer or systemic recurrences
- Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days
- Concomitant use of beta-blockers
- Concomitant nightly use of sleep aids at bedtime
- Working more than one overnight shift per month on a regular basis
Show all 11Show fewer
- Concomitant use of postmenopausal hormone replacement therapy
- Concomitant use of black cohosh, flaxseed or soy in pill or supplement form
- Use of any type of oral melatonin supplementation within the past 30 days
- Use of warfarin (coumadin) within the past 30 days
- Active seizure disorder requiring the use of daily anti-epileptic medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Trial of Oral Melatonin Supplementation in Breast Cancer Survivors
The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.
Read the detailed description
If you agree to participate in this study you will be asked to undergo a blood test to find out if you are eligible. Approximately 2 tablespoons of blood will be drawn. The blood test will check your health and menopausal status. This test will aslo be used to help measure any additional effects of the study drug on your body. If you have had a blood test recently, it may or may not have to be repeated. If these tests show that you are eligible to participate in the research study, you will begin the study. If you do not meet the eligibility criteria, you will not be able to participate.
Because no one knows which of the study options is best, and all of the options are considered likely to work, you will be "randomized" into one of the study groups: melatonin or placebo.
Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in. You will have an equal chance of being placed in either group. Neither you nor the research doctor will know what group you are in. You will not know the identity of your study treatment until after the final research analysis has taken place. Once this has happened, you will be mailed a letter from the principal research doctor telling you which study drug you received while on study.
You will be given a study drug and it will either contain melatonin or placebo (pills with no medical effect). You will take one tablet by mouth every night as close to 9:00 pm as possible. You should not make up missed doses. You will be given enough study drug to last 4 months. You will also be given a study medication-dosing calendar to write down times you took the study drug for each month you are taking the study drug.
Before taking the study drug, you will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. At this visit, you will also be asked to complete a questionnaire that will take approximately 15 minutes.
A member of the research study staff will check in by telephone once a month to monitor your experiences on the research study. You may also contact a member of the research study staff at any time if you have any questions or concerns.
You should tell your research doctor if you are currently taking black cohosh, flaxseed or soy in pill or supplement form, as it may affect your participation in this research study.
After you have completed approximately 4 months of study drug, you will return to clinic to see a member of the research study staff. At this visit you will have the following tests and procedures: You will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. You must return your study medication-dosing calendar and all of your pill bottles at the end of the research study to a member of the research study staff. You wil also be asked to complete a questionnaire that will take about 15 minutes.
- Conditions
- Breast Cancer
- Being tested
- Melatonin 3 mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mgDrug
Also called Melatonin
Melatonin vs. Placebo
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 3 mg | Active comparator | Taken orally, once per day, at/around 9:00pm Receives: Drug: Melatonin 3 mg |
| Placebo | Placebo comparator | Taken orally, once per day, at/around 9:00pm Receives: Drug: Melatonin 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo
Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.
Measured: 4 months
Compliance
To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.
Measured: 4 months
Secondary outcomes (1)
Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months
Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startOct 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Chen, MD, Dana-Farber Cancer Institute
- Investigators
- Wendy Chen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805089
- Sponsor's protocol ID
- 05-305
- Status last verified
- Feb 2015
- First submitted
- 4 Mar 2013
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Oral Melatonin Supplementation in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01805089
- Acronym / sponsor ID
- 05-305
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.
Detailed description
If you agree to participate in this study you will be asked to undergo a blood test to find out if you are eligible. Approximately 2 tablespoons of blood will be drawn. The blood test will check your health and menopausal status. This test will aslo be used to help measure any additional effects of the study drug on your body. If you have had a blood test recently, it may or may not have to be repeated. If these tests show that you are eligible to participate in the research study, you will begin the study. If you do not meet the eligibility criteria, you will not be able to participate.
Because no one knows which of the study options is best, and all of the options are considered likely to work, you will be "randomized" into one of the study groups: melatonin or placebo.
Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in. You will have an equal chance of being placed in either group. Neither you nor the research doctor will know what group you are in. You will not know the identity of your study treatment until after the final research analysis has taken place. Once this has happened, you will be mailed a letter from the principal research doctor telling you which study drug you received while on study.
You will be given a study drug and it will either contain melatonin or placebo (pills with no medical effect). You will take one tablet by mouth every night as close to 9:00 pm as possible. You should not make up missed doses. You will be given enough study drug to last 4 months. You will also be given a study medication-dosing calendar to write down times you took the study drug for each month you are taking the study drug.
Before taking the study drug, you will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. At this visit, you will also be asked to complete a questionnaire that will take approximately 15 minutes.
A member of the research study staff will check in by telephone once a month to monitor your experiences on the research study. You may also contact a member of the research study staff at any time if you have any questions or concerns.
You should tell your research doctor if you are currently taking black cohosh, flaxseed or soy in pill or supplement form, as it may affect your participation in this research study.
After you have completed approximately 4 months of study drug, you will return to clinic to see a member of the research study staff. At this visit you will have the following tests and procedures: You will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. You must return your study medication-dosing calendar and all of your pill bottles at the end of the research study to a member of the research study staff. You wil also be asked to complete a questionnaire that will take about 15 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin 3 mg | Active comparator | Drug: Melatonin 3 mgTaken orally, once per day, at/around 9:00pm |
| Placebo | Placebo comparator | Drug: Melatonin 3 mgTaken orally, once per day, at/around 9:00pm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer
- Not currently receiving chemotherapy or hormonal therapy
- Postmenopausal
Key exclusion criteria (11 listed)
- Stage IV breast cancer or systemic recurrences
- Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days
- Concomitant use of beta-blockers
- Concomitant nightly use of sleep aids at bedtime
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 |
|---|---|---|
| Melatonin 3 mgAlso: MelatoninMelatonin vs. Placebo | Drug | Melatonin 3 mg, Placebo |
Primary outcome
Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo
Time frame: 4 months
Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.
Compliance
Time frame: 4 months
To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.
1 secondary outcome
Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months
Time frame: baseline and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wendy Chen, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin 3 mg in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 3 inclusion and 11 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo (time frame: 4 months). The study lists 2 primary outcomes in all. 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 23 Mar 2015.