Evidence map›Paper›PMID 34674368›Full record

Trial reportPediatric blood & cancer2022

A randomized double-blind placebo-controlled trial of the effectiveness of melatonin on neurocognition and sleep in survivors of childhood cancer.

Margaret M Lubas, Belinda N Mandrell, William L Greene, Carrie R Howell, Robbin Christensen, Cara I Kimberg, Chenghong Li, Kirsten K Ness, Deo Kumar Srivastava, Melissa M Hudson and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric blood & cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Margaret M LubasDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.ORCID 0000-0001-5248-8421
Belinda N MandrellDepartment of Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
William L GreeneDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
Carrie R HowellDepartment of Medicine, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama.ORCID 0000-0002-6554-6237
Robbin ChristensenDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee.
Cara I KimbergDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
Chenghong LiDepartment of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
Kirsten K NessDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.ORCID 0000-0002-2084-1507
Deo Kumar SrivastavaDepartment of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
Melissa M HudsonDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
Leslie L RobisonDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
Kevin R KrullDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.ORCID 0000-0002-0476-7001
Tara M BrinkmanDepartment of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.ORCID 0000-0002-4250-6160
St. Jude Children's Research Hospital · USUniversity of Alabama at Birmingham · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
The St. Jude Lifetime CohortU01CA195547 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI HUDSON, MELISSA M, NESS, KIRSTEN KIMBERLIE · 2015 to 2024
$14.9M
eHealth Intervention for Late Effects of Childhood CancerR01CA239689 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI BRINKMAN, TARA M, KRULL, KEVIN R · 2019 to 2024
$3.4M
Training in Pediatric Cancer Survivorship Outcomes and InterventionsT32CA225590 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI Kevin R Krull · 2018 to 2026
$2.4M
NCI NIH HHS L30 CA179742NCI NIH HHS P30 CA021765NCI NIH HHS R01 CA239689NCI NIH HHS T32 CA225590NCI NIH HHS U01 CA195547
6 · The paper itself

Abstract

backgroundAdult 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.

methodSurvivors (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.

resultsIntent-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).

conclusionMelatonin 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.

Indexed as

Cancer SurvivorsMelatoninNeoplasmsAdultChildDouble-Blind MethodHumansSleepSurvivorsMelatonincognitionmelatoninsleepsurvivorship

Identifiers

PMID34674368
PMCPMC8859989
OpenAlexW3205287165

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.