Interactive time-restricted diet to improve outcomes in patients with brain metastases from breast or lung cancer
Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
This study is testing if a special eating plan can help people with brain cancer from breast or lung cancer feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06315296 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an interactive time-restricted diet intervention, known as txt4fasting, aimed at reducing neurocognitive decline and improving survival in patients with brain metastases from breast or lung cancer. Participants are randomized into two groups: one follows a strict time-restricted diet with positive reinforcement and counseling, while the other receives general healthy eating messages. Both groups undergo stereotactic radiosurgery and are monitored for changes in neurocognitive function and progression-free survival. Blood samples and brain MRIs are collected throughout the study to assess biomarkers and treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed breast or lung cancer and a BMI of 25 kg/m² or higher.
Not a fit: Patients who cannot tolerate a normal diet or are not candidates for stereotactic radiosurgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved cognitive function and survival rates for patients with brain metastases.
How similar studies have performed: While the specific approach of this study is novel, similar dietary interventions have shown promise in improving health outcomes in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Nicole Simone, MD
- Email: Nicole.simone@jefferson.edu
- Phone: 215-955-5289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.