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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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%.

Conditions

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Breast Cancer Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

6 mg oral melatonin daily

Group Type ACTIVE_COMPARATOR

Melatonin (N-acetyl-5-methoxytryptamine)

Intervention Type DRUG

6 mg oral melatonin daily 1 hour before bedtime

Placebo

6 mg oral placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

6 mg oral placebo daily 1 hour before bedtime

Interventions

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Melatonin (N-acetyl-5-methoxytryptamine)

6 mg oral melatonin daily 1 hour before bedtime

Intervention Type DRUG

Placebo

6 mg oral placebo daily 1 hour before bedtime

Intervention Type DRUG

Other Intervention Names

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Melatonin N-acetyl-5-methoxytryptamin

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No