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

Phase 2/Phase 3
30 Years
75 Years
Not Enrolling
Breast Cancer, Depression

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Trial Information

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

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%.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Major Depression Inventory (MDI)

Outcome Description:

MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used as a rating scale/diagnostic instrument. When used as a diagnostic instrument patients are classified as mild, moderate or severe depression or no depression.

Outcome Time Frame:

App. 1 week pre-operatively = day -7

Safety Issue:


Principal Investigator

Melissa V Hansen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herlev Hospital


Denmark: Danish Dataprotection Agency

Study ID:




Start Date:

July 2011

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Depression
  • Breast cancer surgery
  • Melatonin
  • Depression
  • Anxiety
  • Sleep disturbances
  • Cognitive function
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias