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

Launched by THOMAS JEFFERSON UNIVERSITY · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach called an interactive time-restricted diet, known as txt4fasting, to see if it can help reduce mental decline and improve survival for patients with breast or lung cancer that has spread to the brain. This type of cancer, called brain metastases, often leads to more complications and can make treatment more difficult. The trial is focused on patients who are receiving a specific type of radiation therapy called stereotactic radiosurgery, which targets brain tumors with precise doses of radiation. The researchers believe that changing when patients eat—by having longer periods without food—might help improve their overall health and reduce some side effects from treatment.

To be eligible for this trial, participants should be at least 18 years old, have a confirmed diagnosis of breast or lung cancer, and have a body mass index (BMI) of 25 or higher. They should also be candidates for stereotactic radiosurgery, meaning they have a limited number of brain metastases that can be treated. Participants will need to be comfortable with using mobile text messaging, as the program involves interactive communication through texts. Overall, this trial offers an opportunity for patients to potentially improve their health outcomes while undergoing treatment for serious conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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