nctId: NCT06315296 id: iRISID-2023-1985 briefTitle: An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer overallStatus: RECRUITING date: 2023-12-13 date: 2028-06-30 date: 2028-12 date: 2024-03-18 date: 2024-03-18 name: Thomas Jefferson University class: OTHER briefSummary: 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: Anatomic Stage IV Breast Cancer AJCC v8 conditions: Metastatic Breast Carcinoma conditions: Metastatic Lung Carcinoma conditions: Metastatic Malignant Neoplasm in the Brain conditions: Stage IV Lung Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Behavioral Dietary Intervention name: Text Message-Based Navigation Intervention name: Internet-Based Intervention name: Dietary Counseling and Surveillance name: Stereotactic Radiosurgery name: Biospecimen Collection name: Magnetic Resonance Imaging name: Neurocognitive Assessment name: Questionnaire Administration name: Interview name: Internet-Based Intervention name: Stereotactic Radiosurgery name: Text Message-Based Navigation Intervention name: Biospecimen Collection name: Magnetic Resonance Imaging name: Neurocognitive Assessment name: Questionnaire Administration name: Interview measure: Accrual rate measure: Attrition rate measure: Time-restricted eating (TRE) compliance rate measure: Incidence of adverse effects (AEs) measure: Patient satisfaction measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Neurocognitive function decline measure: Intracranial progression free survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sidney Kimmel Cancer Center at Thomas Jefferson University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Nicole Simone role: CONTACT phone: 215-955-6702 email: Nicole.Simone@jefferson.edu lat: 39.95233 lon: -75.16379 hasResults: False