An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer

February 27, 2026 updated by: Thomas Jefferson University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To examine the feasibility and acceptability of the txt4fasting intervention.

SECONDARY OBJECTIVES:

I. 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:

I. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Able to speak, read and write English
  • Negative pregnancy test if childbearing potential
  • Owns a mobile phone with mobile text messaging (TXT) capability

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm I (txt4fasting)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Radiation: Stereotactic Radiosurgery
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
  • SRS
Other: Interview
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo brain MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Medical Imaging
  • Magnetic Resonance / Nuclear Magnetic Resonance
  • nuclear magnetic resonance imaging
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Other: Neurocognitive Assessment
Ancillary studies
Behavioral: Behavioral Dietary Intervention
Follow a time-restricted diet
Other: Text Message-Based Navigation Intervention
Receive interactive positive reinforcement messages
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Other: Internet-Based Intervention
Use txt4fasting platform
Behavioral: Dietary Counseling and Surveillance
Receive counseling calls
Other: Text Message-Based Navigation Intervention
Receive text messages about healthy eating habits and food suggestions
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Active Comparator: Arm II (attention control)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Radiation: Stereotactic Radiosurgery
Undergo SRS
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • stereotactic radiation therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
  • SRS
Other: Interview
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo brain MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Medical Imaging
  • Magnetic Resonance / Nuclear Magnetic Resonance
  • nuclear magnetic resonance imaging
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Other: Neurocognitive Assessment
Ancillary studies
Other: Text Message-Based Navigation Intervention
Receive interactive positive reinforcement messages
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation
Other: Internet-Based Intervention
Use txt4fasting platform
Other: Text Message-Based Navigation Intervention
Receive text messages about healthy eating habits and food suggestions
Other Names:
  • Automated Text Message-Based Navigation
  • Text Message-Based Navigation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 6 months post intervention
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.
Up to 6 months post intervention
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.
Up to 6 months post intervention
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.
Up to 6 months post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurocognitive function decline
Time Frame: At baseline
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.
At baseline
Neurocognitive function decline
Time Frame: at the end of the 30-day intervention
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.
at the end of the 30-day intervention
Neurocognitive function decline
Time Frame: at 3 month follow up
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.
at 3 month follow up
Neurocognitive function decline
Time Frame: at 6 month follow up
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.
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
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.
Time between SRS to progression of brain metastases, assesed up to 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • iRISID-2023-1985
  • JT 31844 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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