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

NCT06315296 | Terminated

• 2 other identifiers: iRISID-2023-1985JT 31844
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Metastatic Breast Carcinoma; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Lung Carcinoma; Metastatic Malignant Neoplasm in the Brain; Stage IV Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Neurocognitive function decline

  At baseline

• Neurocognitive function decline

  at the end of the 30-day intervention

• Neurocognitive function decline

  at 3 month follow up

• Neurocognitive function decline

  at 6 month follow up

• Intracranial progression free survival (PFS)

  Time between SRS to progression of brain metastases, assesed up to 6 months post intervention

Study Arms (2)

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.

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.

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

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Follow a time-restricted diet

Arm I (txt4fasting)

Text Message-Based Navigation Intervention OTHER

Receive interactive positive reinforcement messages

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Arm I (txt4fasting)

Internet-Based Intervention OTHER

Use txt4fasting platform

Arm I (txt4fasting)

Dietary Counseling and Surveillance BEHAVIORAL

Receive counseling calls

Arm I (txt4fasting)

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: SRS, Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Arm I (txt4fasting)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (txt4fasting)

Magnetic Resonance Imaging PROCEDURE

Undergo brain MRI

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI

Arm I (txt4fasting)

Neurocognitive Assessment OTHER

Ancillary studies

Arm I (txt4fasting)

Questionnaire Administration OTHER

Ancillary studies

Arm I (txt4fasting)

Interview OTHER

Ancillary studies

Arm I (txt4fasting)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Brain Neoplasms

Interventions

Nutrition Assessment; Radiosurgery; Specimen Handling; Magnetic Resonance Spectroscopy; X-Rays; Mental Status and Dementia Tests; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: December 13, 2023
• Primary Completion: March 15, 2025
• Study Completion: October 29, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)