A Randomized Trial of Oral Melatonin Supplementation in Breast Cancer Survivors
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
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Evaluate plasma levels after 4 month course of melatonin or placebo
To evaluate changes in plasma levels of estradiol, IGF-1, and IGFBP-3 levels in postmenopausal breast cancer survivors not on hormone therapy after a 4 month course of melatonin or placebo
Wendy Chen, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|