Clinical trial · Interventional
The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients
NCT01355523CI-TRIAL-00014418MELODYterminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inclusion rate not as expected. Not financially possible to involve other centres.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
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 |
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin (N-acetyl-5-methoxytryptamine) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Melatonin
- description
- 6 mg oral melatonin daily
- interventionNames
- Drug: Melatonin (N-acetyl-5-methoxytryptamine)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 6 mg oral placebo daily
- interventionNames
- Drug: Placebo
Primary outcomes (4)
- measure
- Major Depression Inventory (MDI)- Depression at One Point in the Study
- timeFrame
- Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHansen MV, Madsen MT, Andersen LT, Hageman I, Rasmussen LS, Bokmand S, Rosenberg J, Gogenur I. Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. Int J Breast Cancer. 2014;2014:416531. doi: 10.1155/2014/416531. Epub 2014 Aug 27. PMID 25328711