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Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort

NCT01700959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 911

Last updated 2018-06-28

Study results available
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Summary

Primary objective:

1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.

Secondary objectives:

1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors.

This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.

Conditions

  • Cancer Malignancies

Interventions

DRUG

melatonin

Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.

DRUG

placebo

Placebo tablets to match the melatonin will be comprised of inert substances.

Sponsors & Collaborators

Principal Investigators

  • Tara Brinkman, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-06
Primary Completion
2017-04-19
Completion
2017-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01700959 on ClinicalTrials.gov