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Behavioral Intervention

Time-Restricted Diet for Brain Metastases

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a specific diet plan, called txt4fasting, can help reduce brain function decline and improve survival in patients with breast or lung cancer that has spread to the brain.

Who is the study for?

This trial is for breast or lung cancer patients with brain metastases, who will undergo stereotactic radiosurgery. It's designed to see if a special diet plan that changes when you eat can help reduce mental decline and improve survival rates.

What is being tested?

The study tests an interactive diet intervention called txt4fasting, which involves time-restricted eating to potentially benefit the brain after radiation therapy. Patients will also receive dietary counseling and be monitored through various assessments and imaging.

What are the potential side effects?

Specific side effects are not listed, but the intervention may include risks associated with changing diet patterns, such as hunger, fatigue or nutritional deficiencies. Stereotactic radiosurgery can cause headaches, nausea, hair loss at treatment site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accrual rate

Attrition rate

Incidence of adverse effects (AEs)

+2 more

Secondary study objectives

Intracranial progression free survival (PFS)

Neurocognitive function decline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (txt4fasting)Experimental Treatment10 Interventions

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.

Group II: Arm II (attention control)Active Control8 Interventions

Patients receive text messages about healthy eating habits and food suggestions twice daily and record food intake using txt4fasting program for 30 days. Patients then undergo SRS on study. Patients also undergo blood sample collection and brain MRI throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180