Brain TumorSLEPBTNCT05340881
Systematic Light Exposure in Pediatric Brain Tumor Survivors
A study testing Bright Light Exposure, Dim Light Exposure and Cognitive Assessment in people with Brain Tumor, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Bright Light Exposure, Dim Light Exposure and Cognitive Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed and treated for a brain tumor at Texas Children's Hospital
- Treated with either surgery only or surgery and proton beam radiation therapy
- Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates
- Currently or previously enrolled in longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-49380, H-26785, H-41705
- Ages 10-18 years
- At least 1 year post-diagnosis
Show all 11Show fewer
- Endorsed mild to moderate symptoms of fatigue on the PROMIS
- Approval from Long-Term Survivorship provider
- Adequate vision for computerized tasks
- English-speaking
- Intelligence Quotient (IQ) above 70
Who cannot join
- Diagnosis and/or treatment for secondary malignancy in the past 12 months
- Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention
- Presence of photophobia or other eye diseases, seizures, and/or migraines
- Use of photosensitizing medications
- Current or previous use of light therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Kimberly P Raghubar, PhD, (832)822-3713, kpraghub@texaschildrens.org
About this study
Official title: Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors
Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action.
PRIMARY OBJECTIVE:
- To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability. SECONDARY OBJECTIVES:
- To estimate the effect size of change in fatigue associated with bright light exposure.
- To estimate the effect size of change in cognitive efficiency associated with bright light exposure.
Read the detailed description
Participants will be randomized to take part in one of two groups:
- The Bright Light Group will be exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes each day from Monday to Friday for a total of 6 weeks. Duration of light exposure will be gradually increased over the first few days until the target of 30 minutes is reached on Day 5. Light duration is for 10 mins on Days 1 \& 2, 20 mins on Days 3 \& 4, and finally, 30 mins on Day 5.
- The Dim Light Group will be exposed to dim light (equivalent intensity of <25 lux) for a maximum duration of 30 minutes. Dim light will be given in the same manner and frequency as described for the Bright Light group.
Participants will undergo the same evaluations and monitoring throughout the intervention and post-intervention follow-up. All participants will receive a pair of light glasses, with a phone app to track usage, and be fitted with an actigraph following consent to participate. Assessments will be completed at baseline (prior to intervention), with additional assessments at Week 4 (of intervention), Week 6 (end of intervention), and 2-weeks post-intervention (Week 8). Participants and their caregivers will complete questionnaires assessing fatigue, sleep, and mood. Psychological testing to measure attention, working memory, executive control, and processing speed will be completed using a computerized, online battery at each time point and in person at baseline and end of intervention. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history.
At baseline and end of intervention (Week 6), saliva will be collected. For each day of the intervention, participants will share their usage data and complete a daily sleep diary that includes time spent in bed, sleep/wake times, estimated amount of natural sunlight exposure, and medication use. A research coordinator will contact families on Days 2 and 5 and weekly thereafter for the duration of the intervention to identify possible light-related side effects and to check on compliance with light exposure (both frequency and duration). A remote app will be installed on the participant's or caregiver's cell phone to share light usage, which is tracked automatically once the device is turned on. At end of intervention (Week 6), participants and their caregivers will be asked to complete a short acceptability questionnaire.
- Conditions
- Brain Tumor
- Being tested
- Bright Light Exposure, Dim Light Exposure, Cognitive Assessment
- Keywords
- Pediatric Oncology, Fatigue, Cognitive Late Effects, Light Exposure, Sleep, Mood, Brain Tumor
- Medical subject headings
- Brain Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light ExposureBehavioural
Research coordinator will follow-up with participant on Days 2 \& 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued.
Dim Light ExposureBehavioural
Also called Placebo
A placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses.
Cognitive AssessmentOther
Also called Cognitive tests and questionnaires
Cognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo).
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Exposure | Active comparator | Participants are exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. Receives: Behavioral: Bright Light Exposure; Other: Cognitive Assessment |
| Dim Light Exposure | Placebo comparator | Participants are exposed to exposed to dim light (equivalent intensity of <25 lux) using light glasses (Luminette) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. Receives: Behavioral: Dim Light Exposure; Other: Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of approached participants who consent to study participation
The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 70%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
Measured: Once, prior to enrollment
Percent of sessions completed during all 6 weeks of bright or dim light exposure
The rates of light intervention adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 77% of sessions completed on average. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
Measured: At completion of bright or dim light exposure (Week 6)
Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
Measured: Once, at completion of intervention (Week 6)
Secondary outcomes (4)
Change in fatigue outcome
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Measured: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Change in fatigue outcome
For the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, the raw score is converted to a standardized T-score (range 34-85) with a mean of 50 and standard deviation of 10, where a higher score represents greater severity of symptoms. The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on fatigue will be estimated by comparing performance at baseline to that at Week 6 (end of systematic light exposure), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.
Measured: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Change in neurobehavioral outcome
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 4 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 4.
Measured: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Change in neurobehavioral outcome
Attention serves as the primary neurobehavioral endpoint, and it is measured by Omissions T-score (M = 50, SD = 10) from the Conners Continuous Performance Test, Third Edition (CPT-3), where higher scores indicate worse performance (<45 is low and 70+ is very elevated). The effect size (Cohen's d- the standardized difference between two means) of bright light exposure on attention will be estimated by comparing performance at baseline to that at Week 6 (comparison point in adult literature), using the paired difference divided by its estimated standard deviation. In addition, given potential for missing data, a mixed-effect model will be fit to investigate change in outcome from baseline to Week 6.
Measured: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start14 Oct 2022
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital
- Responsible party
- Principal investigator, Kimberly Raghubar, Baylor College of Medicine
- Investigators
- Kimberly P Raghubar, PhD, Principal investigator, Baylor College of MedicineHeather M Conklin, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340881
- Sponsor's protocol ID
- H-50648
- Other IDs
- R21NR019892
- Acronym
- SLEPBT
- Status last verified
- Sep 2025
- First submitted
- 23 Mar 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share de-identified data for all IPD that underlie results in a publication upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Light Exposure Intervention for Fatigue and Cognitive Efficiency in Pediatric Brain Tumor Survivors
- ClinicalTrials.gov ID
- NCT05340881
- Acronym / sponsor ID
- SLEPBT / H-50648
- Conditions
- Brain Tumor
- Keywords
- Pediatric Oncology, Fatigue, Cognitive Late Effects, Light Exposure, Sleep, Mood, Brain Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), St. Jude Children's Research Hospital
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action.
PRIMARY OBJECTIVE:
- To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability. SECONDARY OBJECTIVES:
- To estimate the effect size of change in fatigue associated with bright light exposure.
- To estimate the effect size of change in cognitive efficiency associated with bright light exposure.
Detailed description
Participants will be randomized to take part in one of two groups:
- The Bright Light Group will be exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes each day from Monday to Friday for a total of 6 weeks. Duration of light exposure will be gradually increased over the first few days until the target of 30 minutes is reached on Day 5. Light duration is for 10 mins on Days 1 \& 2, 20 mins on Days 3 \& 4, and finally, 30 mins on Day 5.
- The Dim Light Group will be exposed to dim light (equivalent intensity of <25 lux) for a maximum duration of 30 minutes. Dim light will be given in the same manner and frequency as described for the Bright Light group.
Participants will undergo the same evaluations and monitoring throughout the intervention and post-intervention follow-up. All participants will receive a pair of light glasses, with a phone app to track usage, and be fitted with an actigraph following consent to participate. Assessments will be completed at baseline (prior to intervention), with additional assessments at Week 4 (of intervention), Week 6 (end of intervention), and 2-weeks post-intervention (Week 8). Participants and their caregivers will complete questionnaires assessing fatigue, sleep, and mood. Psychological testing to measure attention, working memory, executive control, and processing speed will be completed using a computerized, online battery at each time point and in person at baseline and end of intervention. Caregivers will also be asked to complete a questionnaire about the family's general characteristics and medical history.
At baseline and end of intervention (Week 6), saliva will be collected. For each day of the intervention, participants will share their usage data and complete a daily sleep diary that includes time spent in bed, sleep/wake times, estimated amount of natural sunlight exposure, and medication use. A research coordinator will contact families on Days 2 and 5 and weekly thereafter for the duration of the intervention to identify possible light-related side effects and to check on compliance with light exposure (both frequency and duration). A remote app will be installed on the participant's or caregiver's cell phone to share light usage, which is tracked automatically once the device is turned on. At end of intervention (Week 6), participants and their caregivers will be asked to complete a short acceptability questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled trial design
| Arm | Type | Receives |
|---|---|---|
| Bright Light Exposure | Active comparator | Behavioral: Bright Light Exposure, Other: Cognitive AssessmentParticipants are exposed to bright light (1,000 lux at eye level) using light glasses (Luminette Version 3) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. |
| Dim Light Exposure | Placebo comparator | Behavioral: Dim Light Exposure, Other: Cognitive AssessmentParticipants are exposed to exposed to dim light (equivalent intensity of <25 lux) using light glasses (Luminette) for a maximum duration of 30 minutes upon awakening each day from Monday to Friday for 6 weeks while wearing an actigraph and periodic completion of questionnaires, cognitive assessments, and lab work. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Diagnosed and treated for a brain tumor at Texas Children's Hospital
- Treated with either surgery only or surgery and proton beam radiation therapy
- Treated for tumors other than high-grade gliomas, brain stem gliomas, or atypical teratoid rhabdoid tumors given associated reduced survival rates
- Currently or previously enrolled in longitudinal studies of neurocognitive outcomes in survivors of pediatric brain tumor (Lisa Kahalley, PI; H-29026, H-35681, H-40804, H-40961, H-49380, H-26785, H-41705
- Ages 10-18 years
Key exclusion criteria (5 listed)
- Diagnosis and/or treatment for secondary malignancy in the past 12 months
- Current or previous (within 12 months) suicidal ideation or severe depression requiring immediate intervention
- Presence of photophobia or other eye diseases, seizures, and/or migraines
- Use of photosensitizing medications
- Current or previous use of light therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light ExposureResearch coordinator will follow-up with participant on Days 2 \& 5, and weekly thereafter to assess for the presence of potential side effects. If side effects are present with bright light initiation and they do not resolve by Day 5, the intervention will be discontinued. | Behavioural | Bright Light Exposure |
| Dim Light ExposureAlso: PlaceboA placebo pair of glasses that is identical in form to the bright light glasses with the exception of light intensity will be used in a manner identical to the bright light glasses. | Behavioural | Dim Light Exposure |
| Cognitive AssessmentAlso: Cognitive tests and questionnairesCognitive examinations will be completed in-person and remotely via an online platform; caregivers and participants will also be asked to complete questionnaires assessing fatigue, sleep, and mood. These outcomes will be completed at baseline (prior to intervention/placebo), Week 4, Week 6 (end of intervention/placebo), and Week 8 (2-weeks post intervention/placebo). | Other | Bright Light Exposure, Dim Light Exposure |
Primary outcome
Percent of approached participants who consent to study participation
Time frame: Once, prior to enrollment
The rates of study participation and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 70%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
Percent of sessions completed during all 6 weeks of bright or dim light exposure
Time frame: At completion of bright or dim light exposure (Week 6)
The rates of light intervention adherence and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 77% of sessions completed on average. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
Percent of participants rating the intervention as acceptable by indicating that they would recommend this intervention to other survivors.
Time frame: Once, at completion of intervention (Week 6)
The rates of completion of cognitive assessments and related 90% Blyth-Still-Casella intervals, as well as their regular 90% confidence interval, will be estimated. Test of one proportion will be performed against an estimated rate of 75%. The rate will be evaluated for the group as a whole as well as separately for the bright light intervention and placebo-control groups.
4 secondary outcomes
Change in fatigue outcome
Time frame: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Change in fatigue outcome
Time frame: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Change in neurobehavioral outcome
Time frame: Baseline (prior to start of intervention) compared to Week 4 (common length of intervention in adult literature)
Change in neurobehavioral outcome
Time frame: Baseline (prior to start of intervention) compared to Week 6 (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. The investigators will share de-identified data for all IPD that underlie results in a publication upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly P Raghubar, PhD principal investigator
Baylor College of Medicine
Heather M Conklin, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Exposure, Dim Light Exposure and Cognitive Assessment in people with Brain Tumor, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly P Raghubar, PhD (832-822-3713, kpraghub@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of approached participants who consent to study participation (time frame: Once, prior to enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.