Trial · NCT01700959

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

NCT01700959, Phase 3, Completed, St. Jude Children's Research Hospital; results first posted 2018-06-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort. Trials, record NCT01700959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01700959

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
NCT number: NCT01700959
Status: Completed
Phases: Phase 3
Enrollment: 911 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Cancer Malignancies
Interventions: melatonin, placebo
First posted: 2012-10-04
Last updated: 2018-06-28
Results first posted: 2018-06-28

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Baseline and 6 months after start of therapy	Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Secondary	Sleep Onset Latency as Measured by Actigraphy and Self-report.	Baseline and six months after start of therapy	Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.
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.	Baseline and six months after start of therapy	Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Baseline and 6 months after start of therapy	Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.	Z-score	MEAN
SECONDARY	Sleep Onset Latency as Measured by Actigraphy and Self-report.	Baseline and six months after start of therapy	Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.	minutes	MEAN
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.	Baseline and six months after start of therapy	Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.	Z-score	NUMBER

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Melatonin: NI Without DSOL	Auditory Attention Difference	0.35	Standard Deviation 1.02	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Placebo: NI Without DSOL	Auditory Attention Difference	0.18	Standard Deviation 0.87	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Melatonin: NI With DSOL	Auditory Attention Difference	0.06	Standard Deviation 1.11	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Placebo: NI With DSOL	Auditory Attention Difference	0.37	Standard Deviation 0.96	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Melatonin: NI Without DSOL	Sustained Attention Difference	0.06	Standard Deviation 1.11	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Placebo: NI Without DSOL	Sustained Attention Difference	0.16	Standard Deviation 1.30	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Melatonin: NI With DSOL	Sustained Attention Difference	0.24	Standard Deviation 1.16	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Placebo: NI With DSOL	Sustained Attention Difference	0.08	Standard Deviation 1.39	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Melatonin: NI Without DSOL	Working Memory Difference	0.17	Standard Deviation 0.67	Z-score
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.	Placebo: NI Without DSOL	Working Memory Difference	0.07	Standard Deviation 0.82	Z-score

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Melatonin: NI Without DSOL	89
Overall Study	STARTED	Placebo: NI Without DSOL	88
Overall Study	STARTED	Melatonin: NI With DSOL	105
Overall Study	STARTED	Placebo: NI With DSOL	105
Overall Study	STARTED	Melatonin: No NI With DSOL	96
Overall Study	STARTED	Placebo: No NI With DSOL	97
Overall Study	COMPLETED	Melatonin: NI Without DSOL	62
Overall Study	COMPLETED	Placebo: NI Without DSOL	64
Overall Study	COMPLETED	Melatonin: NI With DSOL	65
Overall Study	COMPLETED	Placebo: NI With DSOL	70

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events408

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Palpitation	Cardiac disorders	Melatonin: NI Without DSOL	0	58	0
other	Palpitation	Cardiac disorders	Placebo: NI Without DSOL	3	58	3
other	Palpitation	Cardiac disorders	Melatonin: NI With DSOL	2	62	2
other	Palpitation	Cardiac disorders	Placebo: NI With DSOL	3	68	3
other	Palpitation	Cardiac disorders	Melatonin: No NI With DSOL	2	66	2
other	Palpitation	Cardiac disorders	Placebo: No NI With DSOL	6	68	10
other	Sinus tachycardia	Cardiac disorders	Melatonin: NI Without DSOL	2	58	2
other	Sinus tachycardia	Cardiac disorders	Placebo: NI Without DSOL	0	58	0
other	Sinus tachycardia	Cardiac disorders	Melatonin: NI With DSOL	0	62	0
other	Sinus tachycardia	Cardiac disorders	Placebo: NI With DSOL	8	68	10

1 to 10 of 408Source ClinicalTrials.gov

See all 408 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin: NI Without DSOL	0	58
Total, all-cause mortality	Placebo: NI Without DSOL	0	58
Total, all-cause mortality	Melatonin: NI With DSOL	0	62
Total, all-cause mortality	Placebo: NI With DSOL	0	68
Total, all-cause mortality	Melatonin: No NI With DSOL	0	66
Total, all-cause mortality	Placebo: No NI With DSOL	0	68
Total, other adverse events	Melatonin: NI Without DSOL	37	58
Total, other adverse events	Placebo: NI Without DSOL	37	58
Total, other adverse events	Melatonin: NI With DSOL	52	62
Total, other adverse events	Placebo: NI With DSOL	60	68

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA021765	Cancer Center Support Grant (CCSG)	ROBERTS, CHARLES	ST. JUDE CHILDREN'S RESEARCH HOSPITAL	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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