Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function.
Primary Objectives:
- To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
Secondary Objectives:
-
To estimate the efficacy of a tDCS intervention paired with cognitive training.
-
To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
tDCS is a form of non-invasive brain stimulation and is a potentially useful tool to enhance cognitive function. This study uses an at-home intervention of tDCS and cognitive training and examines its potential usefulness at improving executive function in ALL survivors.
Investigators will use tDCS to apply a low electrical current to the participant's scalp in the area of the brain associated with fluent and flexible thinking. The current may make that area of the brain work better for a short period of time. During this time, the participant will play computer games designed to train the brain to work more fluently flexibly. Researchers at St. Jude Children's Research Hospital want to see if pairing the electrical stimulation with the brain games at home is a feasible method to improve cognitive abilities in long-term survivors of childhood ALL.
In the first part of this study, the short-term effect of tDCS intervention will be evaluated in the clinical setting using a randomized cross-over trial. The survivors will be randomized to receive either the tDCS intervention or Sham on day 1, with the other treatment given on day 2. Neurocognitive testing will be conducted within two hours of completing stimulation each day.
In the second part of this study, the feasibility and potential efficacy of self-administration of the tDCS intervention paired with cognitive training will be evaluated over 5 weeks. Research participants will be taught to use the mobile tDCS device and will be provided one to take home. The device will be programmed by the investigators in advance to control the intensity and duration of the stimulation. The research participants will use the device twice per week as directed. Within two hours of completing each tDCS session participants will complete 20 minutes of cognitive training using a mobile app installed on an iPad. Neurocognitive testing will be conducted pre- and post- intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: tDCS on Day 1 On day one, participants will be randomized to receive the transcranial Direct Current Stimulation (tDCS) intervention. On day two, participants receive sham intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. In the second phase of the trial, participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive assessment will be conducted pre- and post-intervention using remote assessment. |
Device: transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level < 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
Other Names:
Device: Sham
The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
Other Names:
Other: Cognitive Assessment
Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized.
The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories.
The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture.
Other Names:
Other: Brain Games Stimulation
Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed.
Other Names:
|
| Active Comparator: tDCS on Day 2 On day one, participants will be randomized to receive sham intervention. On day two, participants receive the transcranial Direct Current Stimulation (tDCS) intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. The second phase of the trial will be conducted the same as for participants in the tDCS on Day 1 arm. Participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive testing will be conducted pre- and post-intervention using remote assessment. |
Device: transcranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level < 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
Other Names:
Device: Sham
The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
Other Names:
Other: Cognitive Assessment
Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized.
The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories.
The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture.
Other Names:
Other: Brain Games Stimulation
Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Feasibility of At Home tDCS Intervention [5 weeks after participant enrollment]
This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.
Secondary Outcome Measures
- Digit Span Forward [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.
- Neurocognitive Questionnaire: CCSS-NCQ [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges: NCQ Task Efficiency: 9-27. NCQ Emotional Regulation: 3-9. NCQ Organization: 3-9. NCQ Memory: 4-12.
- NIH Toolbox Card Sort Task [After active and sham interventions administered on day one and day two of the trial]
The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.
- NIH Toolbox Flanker Task [After active and sham interventions administered on day one and day two of the trial]
The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.
- NIH Toolbox Working Memory Function [After active and sham interventions administered on day one and day two of the trial]
The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.
- Digit Span Backward [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.
- Verbal Fluency [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.
- Oral Trail Making Part A [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.
- Oral Trail Making Part B [Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.]
Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Current St. Jude LIFE (SJLIFE) Protocol Participant
-
Long term survivor of acute lymphoblastic leukemia (ALL)
-
Currently ≥ 18 years of age
-
Wi-Fi internet access at home
-
History of executive dysfunction, documented by neurocognitive testing, and defined as having an age-adjusted standard score <20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward.
-
History of self-reported executive dysfunction in daily life, defined as having a standardized score <20th percentile on BRIEF Initiate, Shift, or Working Memory domains OR having scored <20th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains.
-
Participant is able to speak and understand the English language.
Exclusion Criteria:
-
Any survivor with full scale intelligence quotient (IQ) <80
-
Currently on stimulants or other medications intended to treat cognitive impairment
-
History of seizures
-
No implanted medical devices or implanted metal in the head
-
Currently pregnant or planning to become pregnant.
-
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
Sponsors and Collaborators
- St. Jude Children's Research Hospital
Investigators
- Principal Investigator: Kevin Krull, PhD, St. Jude Children's Research Hospital
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- ALLSTIM
- NCI-2015-00050
Study Results
Participant Flow
| Recruitment Details | Between March 2015 and April 2017, 53 participants were enrolled on study to complete one session of active tDCS and one session of sham tDCS. Participants must complete both to move to the At Home tDCS phase. Twenty participants were excluded due to screening failures. |
|---|---|
| Pre-assignment Detail | Participants, care providers, investigator and outcomes assessor had no knowledge of group assignment. During campus visit, participants received tDCS and sham sessions at day1 or day2 with only order changed due to randomization. A participant was considered as a control for him/herself. For At Home tDCS phase, single arm treatment was conducted. |
| Arm/Group Title | Overall Study |
|---|---|
| Arm/Group Description | Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad. |
| Period Title: Overall Study | |
| STARTED | 33 |
| COMPLETED | 28 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Overall Study |
|---|---|
| Arm/Group Description | During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad. |
| Overall Participants | 31 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
38.2
(9.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
38.7%
|
| Male |
19
61.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
3.2%
|
| Not Hispanic or Latino |
30
96.8%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
3.2%
|
| White |
30
96.8%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Feasibility of At Home tDCS Intervention |
|---|---|
| Description | This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10. |
| Time Frame | 5 weeks after participant enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25) |
| Arm/Group Title | At Home Feasibility of tDCS Intervention |
|---|---|
| Arm/Group Description | All participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. |
| Measure Participants | 28 |
| Count of Participants [Participants] |
25
80.6%
|
| Title | Digit Span Forward |
|---|---|
| Description | Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Pre- At Home tDCS session | Post- At Home tDCS session |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [raw score] |
5.7
(1.0)
|
5.7
(0.9)
|
| Title | Neurocognitive Questionnaire: CCSS-NCQ |
|---|---|
| Description | The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges: NCQ Task Efficiency: 9-27. NCQ Emotional Regulation: 3-9. NCQ Organization: 3-9. NCQ Memory: 4-12. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Participants completed NCQ questionnaire examiner read | Participants completed NCQ questionnaire examiner read |
| Measure Participants | 25 | 25 |
| Task Efficiency |
17.5
(3.3)
|
16.2
(4.0)
|
| Memory |
8.1
(2.4)
|
8.3
(2.0)
|
| Organization |
6.1
(1.7)
|
5.7
(1.6)
|
| Emotional Regulation |
5.9
(2.6)
|
4.7
(1.6)
|
| Title | NIH Toolbox Card Sort Task |
|---|---|
| Description | The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function. |
| Time Frame | After active and sham interventions administered on day one and day two of the trial |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Campus Sham tDCS | On Campus tDCS |
|---|---|---|
| Arm/Group Description | tDCS equipment set to sham condition. | tDCS equipment set to active condition. |
| Measure Participants | 31 | 31 |
| Mean (Standard Deviation) [scores on a scale] |
29.2
(0.6)
|
29.1
(1.4)
|
| Title | NIH Toolbox Flanker Task |
|---|---|
| Description | The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function. |
| Time Frame | After active and sham interventions administered on day one and day two of the trial |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Campus Sham tDCS | On Campus tDCS |
|---|---|---|
| Arm/Group Description | tDCS equipment set to sham condition. | tDCS equipment set to active condition. |
| Measure Participants | 31 | 31 |
| Mean (Standard Deviation) [scores on a scale] |
19.9
(0.4)
|
20.0
(0.0)
|
| Title | NIH Toolbox Working Memory Function |
|---|---|
| Description | The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory. |
| Time Frame | After active and sham interventions administered on day one and day two of the trial |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | On Campus Sham tDCS | On Campus tDCS |
|---|---|---|
| Arm/Group Description | tDCS equipment set to sham condition. | tDCS equipment set to active condition. |
| Measure Participants | 31 | 31 |
| Mean (Standard Deviation) [scores on a scale] |
17.0
(3.2)
|
16.8
(2.9)
|
| Title | Digit Span Backward |
|---|---|
| Description | Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Pre- At Home tDCS session | Post- At Home tDCS session |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [raw score] |
3.7
(1.0)
|
4.2
(1.0)
|
| Title | Verbal Fluency |
|---|---|
| Description | Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Pre- At Home tDCS session | Post- At Home tDCS session |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [raw score] |
33.1
(11.0)
|
34.7
(12.0)
|
| Title | Oral Trail Making Part A |
|---|---|
| Description | Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Pre- At Home tDCS session | Post- At Home tDCS session |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [seconds] |
9.4
(2.6)
|
10.0
(6.7)
|
| Title | Oral Trail Making Part B |
|---|---|
| Description | Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse. |
| Time Frame | Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | At Home tDCS - Baseline | At Home tDCS - Follow-Up |
|---|---|---|
| Arm/Group Description | Pre- At Home tDCS session | Post- At Home tDCS session |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [seconds] |
53.1
(38.9)
|
47.2
(24.0)
|
Adverse Events
| Time Frame | Adverse events were monitored before and after every tDCS session. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | PRISE assesses presence of side effects for several biological systems. For each organ/function system, the participant indicates the presence of a side effect, and if present, the tolerability of the side effect (tolerable or distressing). FISER and GRSEB assess side effect impact: frequency, intensity, and burden. Each domain is rated on a 7- point Likert scale. | |||||
| Arm/Group Title | On Campus Sham tDCS | On Campus tDCS | At Home tDCS | |||
| Arm/Group Description | tDCS equipment set to sham condition. | tDCS equipment set to active condition. | Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. | |||
All Cause Mortality |
||||||
| On Campus Sham tDCS | On Campus tDCS | At Home tDCS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/31 (0%) | 0/28 (0%) | |||
Serious Adverse Events |
||||||
| On Campus Sham tDCS | On Campus tDCS | At Home tDCS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/31 (0%) | 0/28 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| On Campus Sham tDCS | On Campus tDCS | At Home tDCS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/33 (42.4%) | 10/31 (32.3%) | 25/28 (89.3%) | |||
| Ear and labyrinth disorders | ||||||
| Ringing in Ears | 0/33 (0%) | 0/31 (0%) | 4/28 (14.3%) | |||
| General disorders | ||||||
| Headaches | 5/33 (15.2%) | 1/31 (3.2%) | 11/28 (39.3%) | |||
| Fatigue/Restlessness | 0/33 (0%) | 1/31 (3.2%) | 2/28 (7.1%) | |||
| Psychiatric disorders | ||||||
| Vivid Dreams/Nightmares | 2/33 (6.1%) | 2/31 (6.5%) | 9/28 (32.1%) | |||
| Difficulty Sleeping | 0/33 (0%) | 1/31 (3.2%) | 4/28 (14.3%) | |||
| Drowsiness During the Day | 0/33 (0%) | 1/31 (3.2%) | 3/28 (10.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Itching | 9/33 (27.3%) | 8/31 (25.8%) | 6/28 (21.4%) | |||
| Rash | 0/33 (0%) | 1/31 (3.2%) | 2/28 (7.1%) | |||
| Dry Skin | 0/33 (0%) | 1/31 (3.2%) | 2/28 (7.1%) | |||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kevin Krull, PhD |
|---|---|
| Organization | St. Jude Children's Research Hospital |
| Phone | (901) 595-5891 |
| kevin.krull@stjude.org |
- ALLSTIM
- NCI-2015-00050