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Behavioral Intervention

Arm I (txt4fasting) for Lung Cancer

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accrual rate

Attrition rate

Incidence of adverse effects (AEs)

+2 more

Secondary outcome measures

Intracranial progression free survival (PFS)

Neurocognitive function decline

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

Biospecimen Collection

2004

Completed Phase 2

~1700

Behavioral Dietary Intervention

2016

Completed Phase 1

~110

Dietary Counseling and Surveillance

2021

N/A

~40

Stereotactic Radiosurgery

2016

Completed Phase 2

~460

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,429 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for participants in this clinical trial?

"As per clinicaltrials.gov, this study is actively pursuing subjects. It was initially posted on December 13th, 2023 and last revised on March 11th, 2024."

Answered by AI

What is the current number of individuals being enrolled in this clinical investigation?

"Indeed, the information on clinicaltrials.gov shows that this particular trial is actively looking for eligible participants. It was initially posted on December 13, 2023, and last revised on March 11, 2024. The study aims to recruit a total of 60 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer

2023. "An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06315296.

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