Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315296
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief 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
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Txt4fasting An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None