Clinical trial · Interventional
An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IV Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Brain | — | UNRESOLVED | — |
| Stage IV Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Counseling and Surveillance | Behavioral | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Neurocognitive Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (txt4fasting)
- description
- Patients follow a time-restricted diet, receive interactive positive reinforcement messages, and record food intake using the txt4fasting platform daily for 30 days. Patients receive counseling calls twice weekly in weeks 1 and 2 then once weekly in weeks 3 and 4. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.
- interventionNames
- Behavioral: Behavioral Dietary Intervention
- Other: Text Message-Based Navigation Intervention
- Other: Internet-Based Intervention
- Behavioral: Dietary Counseling and Surveillance
- Radiation: Stereotactic Radiosurgery
- Procedure: Biospecimen Collection
- Procedure: Magnetic Resonance Imaging
- Other: Neurocognitive Assessment
- Other: Questionnaire Administration
- Other: Interview
- type
- ACTIVE_COMPARATOR
- label
- Arm II (attention control)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available