TerminatedNot Applicable

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: slow accrual

United States1 participantsStarted 2023-12-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accrual rate

Timeframe: Up to 5 years

Attrition rate

Timeframe: Up to 6 months post intervention

Time-restricted eating (TRE) compliance rate

Timeframe: Up to 6 months post intervention

Incidence of adverse effects (AEs)

Timeframe: Up to 6 months post intervention

Patient satisfaction

Timeframe: Up to 6 months post intervention

Trial details

NCT IDNCT06315296

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

View on ClinicalTrials.gov More Anatomic Stage IV Breast Cancer AJCC v8 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Accrual rate

Timeframe: Up to 5 years

Attrition rate

Timeframe: Up to 6 months post intervention

Time-restricted eating (TRE) compliance rate

Timeframe: Up to 6 months post intervention

Incidence of adverse effects (AEs)

Timeframe: Up to 6 months post intervention

Patient satisfaction

Timeframe: Up to 6 months post intervention