Phase 3
Completed N=580
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Cancer Malignancies
Source: ClinicalTrials.gov NCT01700959 ↗
Enrolled (actual)
580
Serious AEs
8.2%
Results posted
Jun 2018
Primary outcomePrimary: Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. — 0.35; 0.18; 0.06; 0.37 Z-score
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. |
0.35; 0.18; 0.06; 0.37; 0.06; 0.16 | — |
| SECONDARY Sleep Onset Latency as Measured by Actigraphy and Self-report. |
5.66; -10.96; -8.47; 1.95; -20.59; 17.79 | — |
| SECONDARY 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. |
0.22; -0.09; -0.10; -0.16; 0.04; -0.001 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01700959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.