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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315296
• Other study ID #: iRISID-2023-1985
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Nicole Simone, MD
• Phone: 215-955-5289
• Email: Nicole.simone[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Behavioral Dietary Intervention
Follow a time-restricted diet

Other:
• Text Message-Based Navigation Intervention
Receive interactive positive reinforcement messages
• 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
• Magnetic Resonance Imaging
Undergo brain MRI

Other:
• Neurocognitive Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Interview
Ancillary studies
• 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
• Magnetic Resonance Imaging
Undergo brain MRI

Other:
• Neurocognitive Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Interview
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	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.	Up to 5 years
Primary	Attrition rate	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.	Up to 6 months post intervention
Primary	Time-restricted eating (TRE) compliance rate	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.	Up to 6 months post intervention
Primary	Incidence of adverse effects (AEs)	AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events.	Up to 6 months post intervention
Primary	Patient satisfaction	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.	Up to 6 months post intervention
Secondary	Neurocognitive function decline	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.	At baseline
Secondary	Neurocognitive function decline	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.	at the end of the 30-day intervention
Secondary	Neurocognitive function decline	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.	at 3 month follow up
Secondary	Neurocognitive function decline	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.	at 6 month follow up
Secondary	Intracranial progression free survival (PFS)	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.	Time between SRS to progression of brain metastases, assesed up to 6 months post intervention