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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA021765 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-02053 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Primary objective:
Secondary objectives:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Active Comparator | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime. |
|
| Placebo | Placebo Comparator | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | 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. | Baseline and 6 months after start of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency as Measured by Actigraphy and Self-report. | 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. | Baseline and six months after start of therapy |
Not provided
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:
Cohort 2 participant:
Cohort 3 participant:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tara Brinkman, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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The remaining 580 participants were categorized into three mutually exclusive groups: (1) neurocognitive impairment (NI) without delayed sleep onset latency (DSOL), (2) NI with DSOL, and (3) No NI with DSOL. Participants were then randomized to take melatonin or placebo.
911 participants were enrolled and screened between February 2013 and June 2017. Of the 911, 298 were ineligible and 33 withdrew prior to randomization. 580 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin: NI Without DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| FG001 | Placebo: NI Without DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| FG002 | Melatonin: NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| FG003 | Placebo: NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| FG004 | Melatonin: No NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| FG005 | Placebo: No NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin: NI Without DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function. | 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. | Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment. | Posted | Mean | Standard Deviation | Z-score | Baseline and 6 months after start of therapy |
|
Participants were contacted at the end of the first week on study drug then biweekly for the duration of the study, up to 7 months later. Adverse event information was collected by participant reporting and direct questioning.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin: NI Without DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara M. Brinkman, PhD | St. Jude Children's Research Hospital | (901) 595-5683 | tara.brinkman@stjude.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2016 | Mar 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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Not provided
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|
| placebo | Drug | Placebo tablets to match the melatonin will be comprised of inert substances. |
|
| 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. | 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. | Baseline and six months after start of therapy |
| Withdrawal by Subject |
|
| Ineligible |
|
| Noncompliant |
|
| Side effects |
|
| BG001 |
| Placebo: NI Without DSOL |
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| BG002 | Melatonin: NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| BG003 | Placebo: NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| BG004 | Melatonin: No NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| BG005 | Placebo: No NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo: NI Without DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| OG002 | Melatonin: NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| OG003 | Placebo: NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
| OG004 | Melatonin: No NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. |
| OG005 | Placebo: No NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. |
|
|
| Secondary | Sleep Onset Latency as Measured by Actigraphy and Self-report. | 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. | Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment. | Posted | Mean | Standard Deviation | minutes | Baseline and six months after start of therapy |
|
|
|
| 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. | 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. | 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. | Posted | Number | Z-score | Baseline and six months after start of therapy |
|
|
|
| 0 |
| 58 |
| 2 |
| 58 |
| 37 |
| 58 |
| EG001 | Placebo: NI Without DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 0 | 58 | 2 | 58 | 37 | 58 |
| EG002 | Melatonin: NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. | 0 | 62 | 9 | 62 | 52 | 62 |
| EG003 | Placebo: NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 0 | 68 | 6 | 68 | 60 | 68 |
| EG004 | Melatonin: No NI With DSOL | Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime for 6 months. 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. | 0 | 66 | 2 | 66 | 57 | 66 |
| EG005 | Placebo: No NI With DSOL | Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime for 6 months. placebo: Placebo tablets to match the melatonin will be comprised of inert substances. | 0 | 68 | 10 | 68 | 58 | 68 |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gallstones | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ankle fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Cervical cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Trabecular cancer in lungs | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Parotid tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Concentration impairment | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Kidney infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu-like symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Maculo-papular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal dilation | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nightmares | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Delayed orgasm | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Incomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Maculo=papular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Concentration impairment | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Sleet onset latency - self-report |
|
| Working Memory Difference |
|
| Long-term Verbal Memory Difference |
|
| Cognitive Flexibility |
|
| Cognitive Fluency Difference |
|