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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT06315296

Run by

Thomas Jefferson University

People needed

1

Starts

2023-12-13

Expected to finish

2025-10-29

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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