Overview

Melatonin Postoperative Sleep Study in Breast Cancer Patients

Status:
Terminated

Trial end date:
2008-09-01

Target enrollment:
0

Participant gender:
All

Summary

Primary Objective: To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of the quality of sleep and reduction of cardiopulmonary events) during the first postoperative week following anesthesia and surgery in older breast cancer patients receiving a unilateral segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy and axillary node dissection. Secondary Objective: To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction).

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Melatonin

Criteria

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
disease

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