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

NCT ID: NCT06315296

Condition: 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

Conditions: Official terms:
Carcinoma
Lung Neoplasms
Brain Neoplasms
Breast Neoplasms
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Behavioral Dietary Intervention
Description: Follow a time-restricted diet
Arm group label: Arm I (txt4fasting)

Intervention type: Other
Intervention name: Text Message-Based Navigation Intervention
Description: Receive interactive positive reinforcement messages
Arm group label: Arm I (txt4fasting)

Other name: Automated Text Message-Based Navigation

Other name: Text Message-Based Navigation

Intervention type: Other
Intervention name: Internet-Based Intervention
Description: Use txt4fasting platform
Arm group label: Arm I (txt4fasting)

Intervention type: Behavioral
Intervention name: Dietary Counseling and Surveillance
Description: Receive counseling calls
Arm group label: Arm I (txt4fasting)

Intervention type: Radiation
Intervention name: Stereotactic Radiosurgery
Description: Undergo SRS
Arm group label: Arm I (txt4fasting)

Other name: SRS

Other name: Stereotactic External Beam Irradiation

Other name: stereotactic external-beam radiation therapy

Other name: stereotactic radiation therapy

Other name: Stereotactic Radiotherapy

Other name: stereotaxic radiation therapy

Other name: stereotaxic radiosurgery

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Arm I (txt4fasting)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo brain MRI
Arm group label: Arm I (txt4fasting)

Other name: Magnetic Resonance

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging

Other name: Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: MRIs

Other name: NMR Imaging

Other name: NMRI

Other name: nuclear magnetic resonance imaging

Other name: sMRI

Other name: Structural MRI

Intervention type: Other
Intervention name: Neurocognitive Assessment
Description: Ancillary studies
Arm group label: Arm I (txt4fasting)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Arm I (txt4fasting)

Intervention type: Other
Intervention name: Interview
Description: Ancillary studies
Arm group label: Arm I (txt4fasting)

Intervention type: Other
Intervention name: Internet-Based Intervention
Description: Use txt4fasting platform
Arm group label: Arm II (attention control)

Intervention type: Radiation
Intervention name: Stereotactic Radiosurgery
Description: Undergo SRS
Arm group label: Arm II (attention control)

Other name: SRS

Other name: Stereotactic External Beam Irradiation

Other name: stereotactic external-beam radiation therapy

Other name: stereotactic radiation therapy

Other name: Stereotactic Radiotherapy

Other name: stereotaxic radiation therapy

Other name: stereotaxic radiosurgery

Intervention type: Other
Intervention name: Text Message-Based Navigation Intervention
Description: Receive text messages about healthy eating habits and food suggestions
Arm group label: Arm II (attention control)

Other name: Automated Text Message-Based Navigation

Other name: Text Message-Based Navigation

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Arm II (attention control)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo brain MRI
Arm group label: Arm II (attention control)

Other name: Magnetic Resonance

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging

Other name: Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: MRIs

Other name: NMR Imaging

Other name: NMRI

Other name: nuclear magnetic resonance imaging

Other name: sMRI

Other name: Structural MRI

Intervention type: Other
Intervention name: Neurocognitive Assessment
Description: Ancillary studies
Arm group label: Arm II (attention control)

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Arm II (attention control)

Intervention type: Other
Intervention name: Interview
Description: Ancillary studies
Arm group label: Arm II (attention control)

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18 years or older - Pathologically proven breast or lung cancer primary malignancy confirmed - Body mass index (BMI) ≥ 25 kg/m^2 - SRS candidate (1-10 MRI detected brain metastases as per the discretion of radiologist) as determined by the treating physician - Chemotherapy, hormone, and immune therapy will be allowed concurrently - Willing and able to comply with the protocol for the duration of the study - Able to speak, read and write English - Negative pregnancy test if childbearing potential - Owns a mobile phone with mobile text messaging (TXT) capability Exclusion Criteria: - Inability to tolerate a normal diet (may include an active malabsorption syndrome at the time of consent [i.e. Crohn's disease, major bowel resection leading to permanent malabsorption]) - Not a SRS candidate as determined by the treating physician - Prior brain surgery ≤ 14 days prior to enrollment - Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months - Patient with a diagnosis of glioma, or other World Health Organization (WHO) grade II-IV primary brain tumor

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sidney Kimmel Cancer Center at Thomas Jefferson University

Address:
City: Philadelphia
Zip: 19107
Country: United States

Status: Recruiting

Contact:
Last name: Nicole Simone

Phone: 215-955-6702
Email: Nicole.Simone@jefferson.edu

Start date: December 13, 2023

Completion date: December 2028

Lead sponsor:
Agency: Thomas Jefferson University
Agency class: Other

Source: Thomas Jefferson University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06315296

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