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