Anatomic Stage IV Breast Cancer AJCC v8NCT06315296
An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer
A study testing Behavioral Dietary Intervention, Text Message-Based Navigation Intervention and Internet-Based Intervention in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma
- What is being tested?
- Behavioral Dietary Intervention, Text Message-Based Navigation Intervention and Internet-Based Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Pathologically proven breast or lung cancer primary malignancy confirmed
- Body mass index (BMI) ≥ 25 kg/m^2
- SRS candidate (1-10 MRI detected brain metastases as per the discretion of radiologist) as determined by the treating physician
- Chemotherapy, hormone, and immune therapy will be allowed concurrently
- Willing and able to comply with the protocol for the duration of the study
Show all 9Show fewer
- Able to speak, read and write English
- Negative pregnancy test if childbearing potential
- Owns a mobile phone with mobile text messaging (TXT) capability
Who cannot join
- Inability to tolerate a normal diet (may include an active malabsorption syndrome at the time of consent [i.e. Crohn's disease, major bowel resection leading to permanent malabsorption])
- Not a SRS candidate as determined by the treating physician
- Prior brain surgery ≤ 14 days prior to enrollment
- Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
- Patient with a diagnosis of glioma, or other World Health Organization (WHO) grade II-IV primary brain tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To examine the feasibility and acceptability of the txt4fasting intervention.
SECONDARY OBJECTIVES:
- To compare neurocognitive function decline between the intervention and the control arms.
II. To compare progression free survival (PFS) between the intervention and the control arms.
TERTIARY (EXPLORATORY) OBJECTIVE:
- To evaluate the change in biomarkers, from baseline to the end of the study, between the intervention and the control arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo stereostactic radiosurgery (SRS) on study. Patients also undergo blood sample collection and brain magnetic resonance imaging (MRI) throughout study.
ARM II: Patients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.
After completion of study intervention, patients are followed up immediately at the end of the intervention, and at 3 and 6 months.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8
- Being tested
- Behavioral Dietary Intervention, Text Message-Based Navigation Intervention, Internet-Based Intervention, Dietary Counseling and Surveillance, Stereotactic Radiosurgery
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Follow a time-restricted diet
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive interactive positive reinforcement messages
Internet-Based InterventionOther
Use txt4fasting platform
Dietary Counseling and SurveillanceBehavioural
Receive counseling calls
Stereotactic RadiosurgeryRadiation
Also called SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy
Undergo SRS
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging
Undergo brain MRI
Neurocognitive AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
Internet-Based InterventionOther
Use txt4fasting platform
Stereotactic RadiosurgeryRadiation
Also called SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy
Undergo SRS
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive text messages about healthy eating habits and food suggestions
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging
Undergo brain MRI
Neurocognitive AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (txt4fasting) | Experimental | Patients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study. Receives: Behavioral: Behavioral Dietary Intervention; Other: Text Message-Based Navigation Intervention; Other: Internet-Based Intervention; Behavioral: Dietary Counseling and Surveillance; Radiation: Stereotactic Radiosurgery; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Neurocognitive Assessment; Other: Questionnaire Administration; Other: Interview |
| Arm II (attention control) | Active comparator | Patients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study. Receives: Other: Internet-Based Intervention; Radiation: Stereotactic Radiosurgery; Other: Text Message-Based Navigation Intervention; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Neurocognitive Assessment; Other: Questionnaire Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
Feasibility will be defined as 70% of eligible patients reached consent and enroll. Accrual rate will be summarized using percentage and 95% exact confidence intervals.
Measured: Up to 5 years
Attrition rate
Feasibility will be defined as 70% of enrolled participants complete post-intervention follow-up. Attrition rate will be summarized using percentage and 95% exact confidence intervals.
Measured: Up to 6 months post intervention
Time-restricted eating (TRE) compliance rate
Feasibility will be defined as 70% of participants are compliant with 70% of the intervention days with suggested TRE. TRE compliance rate will be summarized using percentage and 95% exact confidence intervals.
Measured: Up to 6 months post intervention
Incidence of adverse effects (AEs)
AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events.
Measured: Up to 6 months post intervention
Patient satisfaction
Acceptability will be measured through a validated treatment satisfaction measure and patient interview data. Acceptability will be established by a group median score ≥ 28 on the Coping Strategies Questionnaire-837. Patient satisfaction will be summarized using percentage and 95% exact confidence intervals.
Measured: Up to 6 months post intervention
Secondary outcomes (5)
Neurocognitive function decline
Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject.
Measured: At baseline
Neurocognitive function decline
Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject.
Measured: at the end of the 30-day intervention
Neurocognitive function decline
Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject.
Measured: at 3 month follow up
Neurocognitive function decline
Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject.
Measured: at 6 month follow up
Intracranial progression free survival (PFS)
Intracranial PFS of brain metastases will be detected by magnetic resonance imaging. Intracranial PFS between the two treatment groups will be compared using a two-sided log-rank test with the significance level of 0.05.
Measured: Time between SRS to progression of brain metastases, assesed up to 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start13 Dec 2023
- Primary completion15 Mar 2025
- Study completion29 Oct 2025
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315296
- Sponsor's protocol ID
- iRISID-2023-1985
- Other IDs
- JT 31844
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
- ClinicalTrials.gov ID
- NCT06315296
- Acronym / sponsor ID
- iRISID-2023-1985
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Neoplasm in the Brain, Stage IV Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 18 Mar 2024 (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.
This clinical trial tests the effectiveness of an interactive time-restricted diet intervention (txt4fasting) in reducing neurocognitive decline and improving survival outcomes after stereotactic radiosurgery in patients with breast or lung cancer that has spread to the brain (brain metastases). Lung cancer and breast cancer are the two most frequent causes of brain metastases. The diagnosis of brain metastases is associated with poorer survival and tumor-induced and treatment-related side effects. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. Patients who receive stereotactic radiosurgery for brain metastases may experience less neurocognitive side effects than with other types of brain radiation, but may still be at risk for their brain metastases growing, spreading, or getting worse. Patients with obesity and diabetes have been shown to have worse survival and increased radiation-related side effects. Evidence demonstrates that simply changing meal timing can have a positive impact on multiple health outcomes. Time-restricted eating, or prolonged nighttime fasting, has been proven to have positive effects on heart disease risk reduction, weight control management and chemotherapy side effect reduction. Txt4fasting may be effective in decreasing neurocognitive decline and improving survival outcomes in patients undergoing stereotactic radiosurgery for brain metastases from breast or lung cancer.
Detailed description
PRIMARY OBJECTIVE:
- To examine the feasibility and acceptability of the txt4fasting intervention.
SECONDARY OBJECTIVES:
- To compare neurocognitive function decline between the intervention and the control arms.
II. To compare progression free survival (PFS) between the intervention and the control arms.
TERTIARY (EXPLORATORY) OBJECTIVE:
- To evaluate the change in biomarkers, from baseline to the end of the study, between the intervention and the control arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo stereostactic radiosurgery (SRS) on study. Patients also undergo blood sample collection and brain magnetic resonance imaging (MRI) throughout study.
ARM II: Patients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.
After completion of study intervention, patients are followed up immediately at the end of the intervention, and at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (txt4fasting) | Experimental | Behavioral: Behavioral Dietary Intervention, Other: Text Message-Based Navigation Intervention, Other: Internet-Based Intervention, Behavioral: Dietary Counseling and Surveillance, Radiation: Stereotactic Radiosurgery, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Neurocognitive Assessment, Other: Questionnaire Administration, Other: InterviewPatients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study. |
| Arm II (attention control) | Active comparator | Other: Internet-Based Intervention, Radiation: Stereotactic Radiosurgery, Other: Text Message-Based Navigation Intervention, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Neurocognitive Assessment, Other: Questionnaire Administration, Other: InterviewPatients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Pathologically proven breast or lung cancer primary malignancy confirmed
- Body mass index (BMI) ≥ 25 kg/m^2
- SRS candidate (1-10 MRI detected brain metastases as per the discretion of radiologist) as determined by the treating physician
- Chemotherapy, hormone, and immune therapy will be allowed concurrently
Key exclusion criteria (5 listed)
- Inability to tolerate a normal diet (may include an active malabsorption syndrome at the time of consent [i.e. Crohn's disease, major bowel resection leading to permanent malabsorption])
- Not a SRS candidate as determined by the treating physician
- Prior brain surgery ≤ 14 days prior to enrollment
- Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
- Patient with a diagnosis of glioma, or other World Health Organization (WHO) grade II-IV primary brain tumor
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 |
|---|---|---|
| Behavioral Dietary InterventionFollow a time-restricted diet | Behavioural | Arm I (txt4fasting) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive interactive positive reinforcement messages | Other | Arm I (txt4fasting) |
| Internet-Based InterventionUse txt4fasting platform | Other | Arm I (txt4fasting) |
| Dietary Counseling and SurveillanceReceive counseling calls | Behavioural | Arm I (txt4fasting) |
| Stereotactic RadiosurgeryAlso: SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapyUndergo SRS | Radiation | Arm I (txt4fasting) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (txt4fasting) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical ImagingUndergo brain MRI | Procedure or surgery | Arm I (txt4fasting) |
| Neurocognitive AssessmentAncillary studies | Other | Arm I (txt4fasting) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (txt4fasting) |
| InterviewAncillary studies | Other | Arm I (txt4fasting) |
| Internet-Based InterventionUse txt4fasting platform | Other | Arm II (attention control) |
| Stereotactic RadiosurgeryAlso: SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapyUndergo SRS | Radiation | Arm II (attention control) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive text messages about healthy eating habits and food suggestions | Other | Arm II (attention control) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm II (attention control) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical ImagingUndergo brain MRI | Procedure or surgery | Arm II (attention control) |
| Neurocognitive AssessmentAncillary studies | Other | Arm II (attention control) |
| Questionnaire AdministrationAncillary studies | Other | Arm II (attention control) |
| InterviewAncillary studies | Other | Arm II (attention control) |
Primary outcome
Accrual rate
Time frame: Up to 5 years
Feasibility will be defined as 70% of eligible patients reached consent and enroll. Accrual rate will be summarized using percentage and 95% exact confidence intervals.
Attrition rate
Time frame: Up to 6 months post intervention
Feasibility will be defined as 70% of enrolled participants complete post-intervention follow-up. Attrition rate will be summarized using percentage and 95% exact confidence intervals.
Time-restricted eating (TRE) compliance rate
Time frame: Up to 6 months post intervention
Feasibility will be defined as 70% of participants are compliant with 70% of the intervention days with suggested TRE. TRE compliance rate will be summarized using percentage and 95% exact confidence intervals.
Incidence of adverse effects (AEs)
Time frame: Up to 6 months post intervention
AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events.
Patient satisfaction
Time frame: Up to 6 months post intervention
Acceptability will be measured through a validated treatment satisfaction measure and patient interview data. Acceptability will be established by a group median score ≥ 28 on the Coping Strategies Questionnaire-837. Patient satisfaction will be summarized using percentage and 95% exact confidence intervals.
5 secondary outcomes
Neurocognitive function decline
Time frame: At baseline
Neurocognitive function decline
Time frame: at the end of the 30-day intervention
Neurocognitive function decline
Time frame: at 3 month follow up
Neurocognitive function decline
Time frame: at 6 month follow up
Intracranial progression free survival (PFS)
Time frame: Time between SRS to progression of brain metastases, assesed up to 6 months post intervention
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention, Text Message-Based Navigation Intervention and Internet-Based Intervention in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Thomas Jefferson University 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 9 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: stopped early, as of the sponsor's last update on 3 Mar 2026. 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. 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?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (time frame: Up to 5 years). The study lists 5 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 3 Mar 2026.