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

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Metastatic Lung Carcinoma
• Metastatic Malignant Neoplasm in the Brain
• Stage IV Lung Cancer AJCC v8

Interventions

BEHAVIORAL

Behavioral Dietary Intervention

Follow a time-restricted diet

OTHER

Text Message-Based Navigation Intervention

Receive interactive positive reinforcement messages

OTHER

Internet-Based Intervention

Use txt4fasting platform

BEHAVIORAL

Dietary Counseling and Surveillance

Receive counseling calls

RADIATION

Stereotactic Radiosurgery

Undergo SRS

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo brain MRI

OTHER

Neurocognitive Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Interview

Ancillary studies

OTHER

Internet-Based Intervention

Use txt4fasting platform

RADIATION

Stereotactic Radiosurgery

Undergo SRS

OTHER

Text Message-Based Navigation Intervention

Receive text messages about healthy eating habits and food suggestions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo brain MRI

OTHER

Neurocognitive Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Interview

Ancillary studies

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-13

Primary Completion

2025-03-15

Completion

2025-10-29

Countries

• United States

Study Locations