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Melatonin Postoperative Sleep Study in Breast Cancer Patients

Phase 1
40 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Melatonin Postoperative Sleep Study in Breast Cancer Patients

Melatonin is produced by a small gland in the brain called the pineal gland. During times
of stress, use of certain medications, and increasing age, melatonin production may be
disrupted or weakened. This may cause sleep disturbance. Many of the drugs used for pain,
anesthesia, or cancer treatment may affect the body's natural secretion of melatonin.

Participants in this study will be randomly assigned (as in the toss of a coin) to one of
two treatment groups. Participants in one group will receive melatonin. Participants in
the other group will receive a placebo. A placebo is a substance that looks like the study
drug, but which has no active ingredients. There is an equal chance of being in either
group. Neither you nor the study doctor will know to which group you are assigned. You will
take either two, three, or four capsules 30 minutes before you go to bed. You will go to
bed at about the same time each day (around 10:00PM). The number of capsules will be
prescribed according to your body weight.

Researchers will attach two monitors to you while you are sleeping to test for changes
during sleep. An actigraph wrist monitor will be worn on the non-dominant wrist (to measure
sleep movement and patterns). A pulse oximeter will be worn on the opposite hand/finger (to
measure the amount of oxygen in the blood). You may use these devices as an inpatient or
outpatient at home.

Each day of the study (for one week after the operation and anesthesia) you will fill out
1-2 questionnaires depending on the day. The researchers will ask questions about your
last night's sleep and how you are feeling. The questionnaires will be filled out each
evening. This will take less than 10 minutes.

If on Day 4 you require any additional sleep medicine or have been experiencing any
unpleasant side effects of melatonin, you may remove yourself from the study. The entire
length of this study is made up of the one week after your surgery. Should you take any
other sleep aids during the time of the study, please tell the research staff as your
questionnaire data cannot then be used for this study.

You will visit your cancer doctor and the study doctor at least one time after your surgery.
This follow-up visit will be coordinated with your surgical postoperative visit.
Researchers may go over some parts of the questionnaires and retrieve the actigraph and
pulse oximeter from you.

This is an investigational study. Melatonin has not gone through the FDA approval
process. However, melatonin supplements are commercially available in over-the-counter
form. Forty patients will take part in this study. All will be enrolled at UTMDACC.

Inclusion Criteria:

1. Breast cancer patients having a unilateral segmental mastectomy, with or without
intraoperative lymph node mapping, sentinel node biopsy, and axillary node dissection

2. Ages >= 40 years

3. American Society of Anesthesiology (ASA) physical status classification of
preoperative functioning) 1-4 levels are acceptable

4. Willing and able to give written informed consent

5. Willing and able to complete questionnaires

6. Not currently taking benzodiazepine medication for insomnia.

Exclusion Criteria:

1. Autoimmune diseases: rheumatoid arthritis, systemic lupus, or other collagen vascular

2. Alcoholics

3. Seizure disorder

4. Thyroid disease

5. Pregnant or lactating patients (effects not known in pregnancy)

6. Renal/hepatic failure (if ood urea nitrogen (BUN) or creatinine (Cr) >2.5* Upper
limit of normal (ULN); Bili or aspartate aminotransferase (AST) or alanine
aminotransferase (ALT)>2.5* ULN)

7. Dementia/poor compliance

8. Manic/psychotic patients

9. Children/adults under 40 yrs

10. Movement disorders (ex. restless leg syndrome)

11. Tremor disorder (ex. parkinsonism)

12. Chronic benzodiazepine use for sleep (>4 times per week )

13. Designated preop medications including melatonin for sleep

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Objective Sleep Response of Patients

Outcome Description:

Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)

Outcome Time Frame:

Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative

Safety Issue:


Principal Investigator

Una Srejic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2004

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Sleep
  • Melatonin
  • Placebo
  • Survey
  • Postoperative Srejic Sleep SAT Survey
  • Breast Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030