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
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.
Interventions
BEHAVIORALBehavioral Dietary Intervention
Follow a time-restricted diet
Receive interactive positive reinforcement messages
OTHERInternet-Based Intervention
Use txt4fasting platform
BEHAVIORALDietary Counseling and Surveillance
Receive counseling calls
RADIATIONStereotactic Radiosurgery
Undergo SRS
PROCEDUREBiospecimen Collection
Undergo blood sample collection
PROCEDUREMagnetic Resonance Imaging
Undergo brain MRI
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rate | Up to 5 years | 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. |
| Attrition rate | Up to 6 months post intervention | 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. |
| Time-restricted eating (TRE) compliance rate | Up to 6 months post intervention | 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. |
| Incidence of adverse effects (AEs) | Up to 6 months post intervention | AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events. |
| Patient satisfaction | Up to 6 months post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive function decline | At baseline | 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 progression free survival (PFS) | Time between SRS to progression of brain metastases, assesed up to 6 months post intervention | 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. |
Countries
United States
Outcome results
None listed