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

St. Jude Children's Research Hospital

Status and phase

Completed

Phase 3

Conditions

Cancer Malignancies

Treatments

Drug: placebo

Drug: melatonin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01700959

P30CA021765 (U.S. NIH Grant/Contract)

NCI-2012-02053 (Registry Identifier)

MIND

Details and patient eligibility

About

Primary objective:

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

Secondary objectives:

To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
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.

Full description

All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions.

Sleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months.

Participants will be divided into 3 mutually exclusive groups:

Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than 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 at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least 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, AND 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.

Within each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months.

Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment.

Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.

Enrollment

911 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital
10 or more years from diagnosis
18 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
Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods

Exclusion criteria

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