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

Melissa Voigt Hansen

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Breast Cancer

Depression

Treatments

Drug: Placebo

Drug: Melatonin (N-acetyl-5-methoxytryptamine)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01355523

2010-022460-12 (EudraCT Number)

MVH-03

2007-58-0015/HEH.750.89-12 (Other Identifier)

H-4-2011-007 (Other Identifier)

Details and patient eligibility

About

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.

Full description

About 1.4 million women are diagnosed with breast cancer every year. Breast cancer is the most common malignancy among women worldwide constituting about 1/5 of all cancer types. Breast cancer diagnosis and treatment, and the months following primary therapy are stressful times for most women. Aside from the actual "cancer threat" many women experience various degrees of depression, anxiety, sleep disturbances and memory/concentration problems (cognitive dysfunction). Naturally these factors influence the quality of life but also contribute to morbidity and mortality.

Melatonin is a regulatory circadian hormone having, among others, hypnotic, sedative, anxiolytic and possibly anti-depressive effects. It has very low toxicity and very few adverse effects.

The purpose of this project is to test melatonin (6 mg daily for 1 week preoperatively to 12 weeks postoperatively) on breast cancer patients and hopefully hereby be able to prevent depression, anxiety, sleep disturbances and cognitive dysfunction. On an overall perspective this will hopefully contribute to improving the quality of life for these patients and extend their lifetime. Furthermore the investigators will be examining whether a specific gene called a clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction. If this is the case it could become possible to identify women with an increased risk and provide prophylactic treatment for those with a risk of developing a depression, sleep disturbances or cognitive disturbances.

Sample size calculations were based on our primary outcome parameter. Using a conservative estimate for the incidence of depression, the investigators expect to find a reduction from 30% to 15% with melatonin treatment. Sample size is sufficient to include our secondary and tertiary outcome parameters as well. The sample size calculations were calculated with a power of 80%, a type I error of 5% and a type II error of 20%.

Enrollment

54 patients

Sex

Female

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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