Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
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Purpose
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.
| 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 |
- 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.
- 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 |
Inclusion Criteria:
- Previously treated at St. Jude Children's Research Hospital
- 10 or more years from diagnosis
- Verbal IQ score > 79
- Performance IQ score > 79
- 18 years of age or older
- Able to speak and understand the English language
- 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
- Known 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 substance 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| Contact: Tara Brinkman, PhD | 866-278-5833 | info@stjude.org |
| 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 | |
| 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 |
| Study First Received: | September 25, 2012 |
| Last Updated: | February 4, 2013 |
| 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 May 19, 2013