Clinical trial · Interventional
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| melatonin | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Melatonin
- description
- Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
- interventionNames
- Drug: melatonin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available