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.