Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Lung Neoplasms

Carcinoma

Neoplasm Metastasis

Breast Neoplasms

Brain Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Breast Diseases

Skin Diseases

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.

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.

Behavioral Dietary Intervention

Receive interactive positive reinforcement messages

Text Message-Based Navigation Intervention

Internet-Based Intervention

Dietary Counseling and Surveillance

Stereotactic Radiosurgery

Biospecimen Collection

Magnetic Resonance Imaging

Neurocognitive Assessment

Questionnaire Administration

Interview

Receive text messages about healthy eating habits and food suggestions

Nicole Simone, MD

Nicole Simone

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 OBJECTIVE:

I. To examine the feasibility and acceptability of the txt4fasting intervention.

SECONDARY OBJECTIVES:

I. To compare neurocognitive function decline between the intervention and the control arms.

II. To compare progression free survival (PFS) between the intervention and the control arms.

TERTIARY (EXPLORATORY) OBJECTIVE:

I. To evaluate the change in biomarkers, from baseline to the end of the study, between the intervention and the control arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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 stereostactic radiosurgery (SRS) on study. Patients also undergo blood sample collection and brain magnetic resonance imaging (MRI) throughout study.

ARM II: 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.

After completion of study intervention, patients are followed up immediately at the end of the intervention, and at 3 and 6 months.

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

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.

Feasibility will be defined as 70% of enrolled participants complete post-intervention follow-up. Attrition rate will be summarized using percentage and 95% exact confidence intervals.

Feasibility will be defined as 70% of participants are compliant with 70% of the intervention days with suggested TRE. TRE compliance rate will be summarized using percentage and 95% exact confidence intervals.

AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events.

Acceptability will be measured through a validated treatment satisfaction measure and patient interview data. Acceptability will be established by a group median score ≥ 28 on the Coping Strategies Questionnaire-837. Patient satisfaction will be summarized using percentage and 95% exact confidence intervals.

Neurocognitive function decline will be measured on the Cambridge Neuropsychological Test Automated Battery. Each of the five endpoints will be modeled using linear mixed-effects models with the fixed effects of treatment arm and time as well as their interaction, and random effect of the subject.

Intracranial PFS of brain metastases will be detected by magnetic resonance imaging. Intracranial PFS between the two treatment groups will be compared using a two-sided log-rank test with the significance level of 0.05.

Thomas Jefferson University

Nutritional and Metabolic Diseases

Obesity

Body Weight

Weight Loss

Overweight

Overnutrition

Nutrition Disorders

Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes.

Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.

Exercise Intervention

Informational Intervention

Receive telephone-based weight loss intervention

Telephone-Based Intervention

Brian C Focht, PhD

This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility and acceptability of a 15-week telephone-based weight loss intervention among overweight/obese rural residents.

II. To estimate the preliminary efficacy of the lifestyle modifications on weight loss, body composition (fat mass, percent body fat), inflammatory biomarkers (IL-6, TNF-alpha, and C-recreative protein \[CRP\]), and other disease risk factors (lipid profiles).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes.

ARM II: Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.

Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio

Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio

Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be obtained by fasting capillary blood sampling from fingerstick and analyzed using Cholestech LDX

C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer

Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays

TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme

Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task

Self-reported using Leisure-Time Exercise Questionnaires118. Objectively measured physical activity will be recorded using the LIFECORDER Plus Accelerometer for 7 days in the 1st and 15th week

Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales

Self-reported using the National Institutes of Health Daily Food List

Will be defined as the percentage of enrolled participants who complete the study.

Changes in body weight (KG)will be measured by a weight scale

Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer	NCT06315296	Anatomic Stage ... Metastatic Brea... Metastatic Lung... Metastatic Mali... Stage IV Lung C...	Behavioral Diet... Text Message-Ba... Internet-Based ... Dietary Counsel... Stereotactic Ra... Biospecimen Col... Magnetic Resona... Neurocognitive ... Questionnaire A... Interview Internet-Based ... Stereotactic Ra... Text Message-Ba... Biospecimen Col... Magnetic Resona... Neurocognitive ... Questionnaire A... Interview	18 Years -	Thomas Jefferson University
An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer	NCT06315296	Anatomic Stage ... Metastatic Brea... Metastatic Lung... Metastatic Mali... Stage IV Lung C...	Behavioral Diet... Text Message-Ba... Internet-Based ... Dietary Counsel... Stereotactic Ra... Biospecimen Col... Magnetic Resona... Neurocognitive ... Questionnaire A... Interview Internet-Based ... Stereotactic Ra... Text Message-Ba... Biospecimen Col... Magnetic Resona... Neurocognitive ... Questionnaire A... Interview	18 Years -	Thomas Jefferson University
Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio	NCT05040152	Obesity-Related...	Dietary Counsel... Exercise Interv... Informational I... Questionnaire A... Telephone-Based...	20 Years - 64 Years	Ohio State University Comprehensive Cancer Center

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