Clinical trial · Interventional
Melatonin Postoperative Sleep Study in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to low accrual.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Melatonin
- description
- 0.15 mg/kg capsules by mouth daily
- interventionNames
- Drug: Melatonin
- Behavioral: Questionnaire
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Starch capsules by mouth daily
- interventionNames
- Drug: Placebo
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Objective Sleep Response of Patients
- timeFrame
- Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available