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

NCT01700959 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: MINDP30CA021765NCI-2012-02053
• Study Type: interventional
• Target: 911
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective:

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

Conditions

Cancer Malignancies

Keywords

Melatonin; Neurocognitive impairment; Sleep disturbance; Childhood cancer survivors

Outcome Measures

Primary Outcomes (1)

• Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.

  Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.

  Baseline and 6 months after start of therapy

Secondary Outcomes (2)

• Sleep Onset Latency as Measured by Actigraphy and Self-report.

  Baseline and six months after start of therapy

• Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.

  Baseline and six months after start of therapy

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.

Drug: melatonin

Placebo

PLACEBO COMPARATOR

Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.

Drug: placebo

Interventions

melatonin DRUG

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.

Also known as: N-Acetyl-5-Methoxytryptamine

Melatonin

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital
• or more years from diagnosis
• years of age or older
• Able to speak and understand the English language
• Participant has a full scale intelligence quotient (FSIQ) score \>79.
• Cohort 1 participant:
• Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
• Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes \< once a week during the past month.
• Cohort 2 participant:
• Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
• Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.
• Cohort 3 participant:
• Is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning.
• Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.
• Female participant of childbearing age must not be pregnant or lactating

You may not qualify if:

• Known allergy to melatonin or any ingredients of the study product or placebo
• Participant currently is taking melatonin
• Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)
• Known diabetes mellitus - insulin treated
• Participant has uncontrolled seizure disorder in past 12 months
• Reported current illicit drug or alcohol abuse or dependence
• Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder)
• Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R))
• Employed in a position that requires night work (i.e. 10pm to 6am)
• Females who are pregnant or lactating/nursing
• History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment
• Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Tara M. Brinkman, PhD
• Organization: St. Jude Children's Research Hospital

tara.brinkman@stjude.org

(901) 595-5683

Study Officials

• Tara Brinkman, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 4, 2012
• Study Start: February 6, 2013
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: June 28, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-03

Locations

US (1)