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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title: Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes

Status Recruiting

Clinical 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). 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06315296
• Study type: Interventional
• Source: Thomas Jefferson University
• Contact: Nicole Simone, MD
• Phone: 215-955-5289
• Email: Nicole.simone@jefferson.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Completion date: December 2028