The effect of melatonin on depression, anxiety, cogntive function and sleep disturbances in breast cancer patients - MELODY

Conditions: DepressionAnxiety Postoperative cognitive dysfunctionSleep disturbances
MedDRA version: 12.1Level: LLTClassification code 10012378Term: Depression
MedDRA version: 12.1Level: LLTClassification code 10002855Term: Anxiety
MedDRA version: 12.1Level: LLTClassification code 10009845Term: Cognitive disturbance
MedDRA version: 12.1Level: LLTClassification code 10040997Term: Sleep disturbances

Registration Number: EUCTR2010-022460-12-DK

Lead Sponsor: Herlev Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Women aged 30-70 years who are admitted to have a lumpectomy or mastectomy at Herlev Hospital - department F.
ASA score I-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known and treated sleep apnea syndrome
2.Diabetes mellitus – treated with insulin
3.Known depressive illness - medically treated
4.Previous medically treated depression or bipolar disorder
5.Previous or ongoing cancer-disease
6.Other medically treated sleep disorders
7.Shiftwork
8.Pre-operative treatment with psychopharmaceuticals (narcotics and sedatives)
9.Pregnant or breastfeeding women
10.Pre-operative mini mental state examination score (MMSE) < 24
11. Planned or on-going preoperative chemotherapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if melatonin has an effect on depressive symptoms measured by MDI (Major Depression Inventory) in breast cancer patients;Secondary Objective: To investigate if melatonin has an effect on anxiety, cognitive dysfunction and sleep disturbances in breast cancer patients;Primary end point(s): Major Depression Inventory (MDI) to determine depressive symptoms

Secondary Outcome Measures