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NCT06315296 · ClinicalTrials.gov registry record · NA
An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer
A NA study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT06315296: Clinical Trial NA study, sponsored by Thomas Jefferson University.
NCT06315296 is a NA study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315296, a NA study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
Feasibility will be defined as 70% of eligible patients reached consent and enroll. Accrual rate will be summarized using percentage and 95% exact confidence intervals.
Interventions
- RADIATION Stereotactic Radiosurgery
- OTHER Internet-Based Intervention
- BEHAVIORAL Behavioral Dietary Intervention
- OTHER Text Message-Based Navigation Intervention
- BEHAVIORAL Dietary Counseling and Surveillance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2025-10-29 |
| Phase | NA |
Why NCT06315296 stopped before completion
NCT06315296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 5 interventions - of which Stereotactic Radiosurgery is the first listed.
NCT06315296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06315296 about?
NCT06315296 is a clinical study titled "An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer". 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). Lun...
What is the current status of trial NCT06315296?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2023-12-13. Estimated completion is 2025-10-29.
What interventions are being tested in trial NCT06315296?
The interventions under investigation include: Stereotactic Radiosurgery (RADIATION), Internet-Based Intervention (OTHER), Behavioral Dietary Intervention (BEHAVIORAL), Text Message-Based Navigation Intervention (OTHER), Dietary Counseling and Surveillance (BEHAVIORAL).
Who is sponsoring clinical trial NCT06315296?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06315296's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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