Melatonin Postoperative Sleep Study in Breast Cancer Patients
Status:
Terminated
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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).