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| ID | Type | Description | Link |
|---|---|---|---|
| JT 31844 | Other Identifier | JeffTrial Number |
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slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (txt4fasting) | Experimental | 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 SRS on study. Patients also undergo blood sample collection and brain MRI throughout study. |
|
| Arm II (attention control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Follow a time-restricted diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Text Message-Based Navigation Intervention |
| Other |
Receive interactive positive reinforcement messages |
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| Internet-Based Intervention | Other | Use txt4fasting platform |
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| Dietary Counseling and Surveillance | Behavioral | Receive counseling calls |
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| Stereotactic Radiosurgery | Radiation | Undergo SRS |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Magnetic Resonance Imaging | Procedure | Undergo brain MRI |
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| Neurocognitive Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| Internet-Based Intervention | Other | Use txt4fasting platform |
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| Stereotactic Radiosurgery | Radiation | Undergo SRS |
|
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| Text Message-Based Navigation Intervention | Other | Receive text messages about healthy eating habits and food suggestions |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
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| Magnetic Resonance Imaging | Procedure | Undergo brain MRI |
|
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| Neurocognitive Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D016634 | Radiosurgery |
| D013048 | Specimen Handling |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| D000073216 | Mental Status and Dementia Tests |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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