The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive function and sleep disturbances in breast cancer patients. Furthermore the investigators will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melissa Voigt Hansen
• Collaborators: Pharma Nord; Rigshospitalet, Denmark; University of Copenhagen
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Women, age 30-75, with breast cancer who are admitted for a lumpectomy or mastectomy at Herlev Hospital

• ASA score I-III

• No sign of depression measured my Major Depression Inventory (MDI)

• Not pregnant

Exclusion Criteria:

• Neoadjuvant chemotherapy

• Treatment with SSRI, Warfarin or other anticoagulants (except 75 mg ASA daily), MAO inhibitors or calcium blockers

• Rotor or Dubin-Johnson syndrome

• Epilepsy

• Known allergic reaction to melatonin

• Known and treated sleep apnea

• Diabetes Mellitus - insulin treated

• Ongoing or previous medically treated depression or bipolar disorder

• Known autoimmune diseases - systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and sclerose

• Incompensated liver cirrhosis

• Severe kidney disease

• Previous or current cancer

• Known medically treated sleep-disorder (insomnia, restless legs etc)

• Shift-work and night-work

• Daily alcohol intake of more than 5 units

• Pre-operative treatment with psychopharmacological drugs, opioids or anxiolytics (including all sleeping pills)

• Predicted bad compliance

• Pregnant or breast-feeding

• Pre-operative Mini Mental State Evaluation (MMSE) score less than 24