RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-13
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06315296

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Pathologically proven breast or lung cancer primary malignancy confirmed
  3. * Body mass index (BMI) ≥ 25 kg/m\^2
  4. * SRS candidate (1-10 MRI detected brain metastases as per the discretion of radiologist) as determined by the treating physician
  5. * Chemotherapy, hormone, and immune therapy will be allowed concurrently
  6. * Willing and able to comply with the protocol for the duration of the study
  7. * Able to speak, read and write English
  8. * Negative pregnancy test if childbearing potential
  9. * Owns a mobile phone with mobile text messaging (TXT) capability
  1. * Inability to tolerate a normal diet (may include an active malabsorption syndrome at the time of consent \[i.e. Crohn's disease, major bowel resection leading to permanent malabsorption\])
  2. * Not a SRS candidate as determined by the treating physician
  3. * Prior brain surgery ≤ 14 days prior to enrollment
  4. * Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
  5. * Patient with a diagnosis of glioma, or other World Health Organization (WHO) grade II-IV primary brain tumor

Contacts and Locations

Study Contact

Nicole Simone, MD
CONTACT
215-955-5289
Nicole.simone@jefferson.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

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