Clinical trial NCT06315296: An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Survival in Patients With Brain Metastases From Breast or Lung Cancer
Official title: Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Accrual rate
timeFrame: Up to 5 years
measure: Attrition rate
timeFrame: Up to 6 months post intervention
measure: Time-restricted eating (TRE) compliance rate
timeFrame: Up to 6 months post intervention
measure: Incidence of adverse effects (AEs)
timeFrame: Up to 6 months post intervention
measure: Patient satisfaction
timeFrame: Up to 6 months post intervention
Secondary outcomes:
measure: Neurocognitive function decline
timeFrame: At baseline
measure: Neurocognitive function decline
timeFrame: at the end of the 30-day intervention
measure: Neurocognitive function decline
timeFrame: at 3 month follow up
measure: Neurocognitive function decline
timeFrame: at 6 month follow up
measure: Intracranial progression free survival (PFS)
timeFrame: Time between SRS to progression of brain metastases, assesed up to 6 months post intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: