Melatonin Postoperative Sleep Study in Breast Cancer Patients
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT00506064
- Run by
- M.D. Anderson Cancer Center
- People needed
- 4
- Starts
- 2004-02-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2012-12-05
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Breast cancer patients having a unilateral segmental mastectomy, with or without intraoperative lymph node mapping, sentinel node biopsy, and axillary node dissection
- Ages >= 40 years
- American Society of Anesthesiology (ASA) physical status classification of preoperative functioning) 1-4 levels are acceptable
- Willing and able to give written informed consent
- Willing and able to complete questionnaires
- Not currently taking benzodiazepine medication for insomnia.
You may not qualify if…
- Autoimmune diseases: rheumatoid arthritis, systemic lupus, or other collagen vascular disease
- Alcoholics
- Seizure disorder
- Thyroid disease
- Pregnant or lactating patients (effects not known in pregnancy)
- 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)
- Dementia/poor compliance
- Manic/psychotic patients
- Children/adults under 40 yrs
- Movement disorders (ex. restless leg syndrome)
- Tremor disorder (ex. parkinsonism)
- Chronic benzodiazepine use for sleep (>4 times per week )
- Designated preop medications including melatonin for sleep
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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