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

This study is currently recruiting participants.
Verified March 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01700959
First received: September 25, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cancer Malignancies
Drug: melatonin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Neurocognitive function as measured by performance on standardized tests of attention, memory, and executive function. [ Time Frame: Baseline and 6 months after start of therapy ] [ Designated as safety issue: No ]

    Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2).

    The measures will be analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups.



Secondary Outcome Measures:
  • Sleep onset latency as measured by actigraphy and self-report. [ Time Frame: Baseline, three, and six months after start of therapy ] [ Designated as safety issue: No ]

    Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3).

    The measures will be analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.


  • 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. [ Time Frame: Baseline and six months after start of therapy ] [ Designated as safety issue: No ]

    Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2).

    Change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency.



Estimated Enrollment: 457
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
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.
Other Name: N-Acetyl-5-Methoxytryptamine
Placebo Comparator: Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
Drug: placebo
Placebo tablets to match the melatonin will be comprised of inert substances.
Other Name: placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700959

Contacts
Contact: Tara Brinkman, PhD 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Tara Brinkman, PhD    866-278-5833    info@stjude.org   
Principal Investigator: Tara Brinkman, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Tara Brinkman, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01700959     History of Changes
Other Study ID Numbers: MIND, P30CA021765
Study First Received: September 25, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Melatonin
Neurocognitive impairment
Sleep disturbance
Childhood cancer survivors

Additional relevant MeSH terms:
Neoplasms
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 22, 2014