protocolSection identificationModule nctId: NCT06315296, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Thomas Jefferson University, class: OTHER, descriptionModule 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., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Dietary Intervention, interventions name: Text Message-Based Navigation Intervention, interventions name: Internet-Based Intervention, interventions name: Dietary Counseling and Surveillance, interventions name: Stereotactic Radiosurgery, interventions name: Biospecimen Collection, interventions name: Magnetic Resonance Imaging, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, interventions name: Interview, interventions name: Internet-Based Intervention, interventions name: Stereotactic Radiosurgery, interventions name: Text Message-Based Navigation Intervention, interventions name: Biospecimen Collection, interventions name: Magnetic Resonance Imaging, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, interventions name: Interview, outcomesModule primaryOutcomes measure: Accrual rate, primaryOutcomes measure: Attrition rate, primaryOutcomes measure: Time-restricted eating (TRE) compliance rate, primaryOutcomes measure: Incidence of adverse effects (AEs), primaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Neurocognitive function decline, secondaryOutcomes measure: Intracranial progression free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sidney Kimmel Cancer Center at Thomas Jefferson University, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Nicole Simone, role: CONTACT, phone: 215-955-6702, email: Nicole.Simone@jefferson.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False