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

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: Terminated
• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Metastatic Malignant Neoplasm in the Brain; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Radiation: Stereotactic Radiosurgery; Other: Interview; Procedure: Magnetic Resonance Imaging; Other: Neurocognitive Assessment; Behavioral: Behavioral Dietary Intervention; Other: Text Message-Based Navigation Intervention; Other: Internet-Based Intervention; Behavioral: Dietary Counseling and Surveillance; Other: Text Message-Based Navigation Intervention

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: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Time between SRS to progression of brain metastases, assesed up to 6 months post intervention

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Skin and Connective Tissue Diseases; Lung Neoplasms; Breast Neoplasms; Brain Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Phenomena; Behavioral Disciplines and Activities; Chemistry Techniques, Analytical; Spectrum Analysis; Electromagnetic Phenomena; Magnetic Phenomena; Epidemiologic Measurements; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Psychological Tests; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Neuropsychological Tests; Interviews as Topic; Specimen Handling; Magnetic Resonance Spectroscopy; Radiosurgery; X-Rays; Nutrition Assessment; Mental Status and Dementia Tests
• Other Study ID 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