A randomized double‐blind placebo‐controlled trial of the effectiveness of melatonin on neurocognition and sleep in survivors of childhood cancer. Issue 1 (21st October 2021)

• Record Type: Journal Article
• Authors: Lubas, Margaret M.; Mandrell, Belinda N.; Greene, William L.; Howell, Carrie R.; Christensen, Robbin; Kimberg, Cara I.; Li, Chenghong; Ness, Kirsten K.; Srivastava, Deo Kumar; Hudson, Melissa M.; Robison, Leslie L.; Krull, Kevin R.; Brinkman, Tara M.
• Is Part Of: Pediatric blood & cancer. Volume 69:Issue 1(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-10-21
• Subjects: cognition -- melatonin -- sleep -- survivorship; Tumors in children -- Periodicals; Blood -- Diseases -- Periodicals; Cancer in children -- Periodicals; 618.92
• DOI: 10.1002/pbc.29393
• Languages: English
• ISSNs: 1545-5009

Abstract

Abstract: Background: Adult survivors of childhood cancer are at risk of developing sleep and neurocognitive problems, yet few efficacious interventions exist targeting these prevalent late effects. Melatonin has known sleep‐promoting effects; however, it has not been well studied among childhood cancer survivors. Method: Survivors ( n = 580; mean age = 33.5 years; 26 years post‐diagnosis) from the St. Jude Lifetime Cohort were randomized (1:1) to a six‐month double‐blind placebo‐controlled trial of 3 mg time‐release melatonin within three strata (stratum 1: neurocognitive impairment only; stratum 2: neurocognitive and sleep impairment; stratum 3: sleep impairment only). Neurocognitive performance was assessed at baseline and post‐intervention using standardized measures. Sleep was assessed via self‐report and actigraphy. Independent sample t tests compared mean change scores from baseline to six months. Post‐hoc analyses compared the prevalence of clinically significant treatment responders among melatonin and placebo conditions within and across strata. Results: Intent‐to‐treat analyses revealed no statistically significant differences in neurocognitive performance or sleep from baseline to post‐intervention. However, among survivors with neurocognitive impairment only, a larger proportion randomized to melatonin versus placebo demonstrated a treatment response for visuomotor speed (63% vs 41%, P = 0.02) and nonverbal reasoning (46% vs 28%, P = 0.04). Among survivors with sleep impairment only, a larger proportion treated with melatonin demonstrated a treatment response for shifting attention (44% vs 28%, P = 0.05), short‐term memory (39% vs 19%, P = 0.01), and actigraphy‐assessed sleep duration (47% vs 29%, P = 0.05). Conclusion: Melatonin was not associated with improved neurocognitive performance or sleep in our intent‐to‐treat analyses; however, a subset of survivors demonstrated a clinically significant treatment response.