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STUDY OBJECTIVES: To investigate whether administration of an oral dose of 6 mg melatonin before bedtime perioperatively in breast cancer surgery could change sleep outcomes measured by actigraphy.METHODS: This paper reports secondary outcomes from a double-blind, placebo-controlled, randomized clinical trial where patients received 6 mg melatonin (n = 27) or placebo (n = 21) approximately 60 minutes before bedtime 3 nights preoperatively until at least one week postoperatively. Participants were monitored in the entire period with actigraphy, and were instructed to complete visual analogue scale (VAS) for sleep, and the Karolinska Sleepiness Scale (KSS) each morning.RESULTS: Administration of 6 mg oral melatonin approximately 1 hour before bedtime resulted in significantly increased sleep efficiency and reduced wake after sleep onset for the entire 2-week postoperative period. No other significant differences for actigraphy determined sleep outcomes or subjective outcome parameters in the perioperative period were found between the groups. Overall, the patients sleep outcomes were within normal ranges and no participants had pathological sleep disturbances.CONCLUSIONS: Melatonin significantly changed sleep efficiency and wake after sleep onset after surgery, but had no effects on other objective sleep outcomes or on subjective sleep quality (VAS and KSS).

BACKGROUND: To determine use and investigate factors associated with use of hypnotics the first year after a diagnosis with breast cancer.MATERIAL AND METHODS: A retrospective registry based cohort study linking clinical data from the Danish Breast Cancer Group with the National Prescription Drug Database and other health and administrative registries. We included 26 082 women diagnosed with early breast cancer as first time primary cancer during 1996-2006. Use of hypnotics was measured as redeemed prescriptions in the first year after diagnosis of early breast cancer. Prior use of hypnotics was defined as one or more prescriptions of hypnotics 13 months to 1 month before diagnosis, and chronic use was defined as four or more prescriptions. Hazard ratios (HRs) for clinical variables, treatment-related factors and sociodemographic factors were calculated.RESULTS: Among women with no prior history of hypnotic use, 17% became new users with 4% on a chronic level. Among prior users, 82% continued their use with one or more prescriptions of hypnotics and 15% increased their use to a chronic level. Significantly increased hazard ratios for use of hypnotics were seen with increasing age [age 50-59 years: HR 1.43 (95% CI 1.31-1.57), age 60-69: HR 1.57 (95% CI 1.44-1.71)], increasing number of tumor positive lymph nodes [1-3 lymph nodes: HR 1.12 (95% CI 1.05-1.09), 4-9 lymph nodes: HR 1.11 (95% CI 1.02-1.29)], chemotherapy [HR 1.25 (95% CI 1.12-1.39)], somatic comorbidity [HR 1.31 (95% CI 1.21-1.42)] and use of antidepressants the year before breast cancer diagnosis [HR 1.97 (95% CI 1.85-2.10)].CONCLUSION: This study detected a group of patients at great risk for initiating and increasing use of hypnotics and preventive and prophylactic mechanism should be investigated and initiated when this group of patients is seen in the clinical setting.

Background. Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery. Methods. This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30-75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS. Results. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26); 11 withdrew (10 placebo, 1 melatonin, P = 0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P = 1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P = 0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P = 0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P = 0.03). Conclusion. Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.gov NCT01355523.