Txt4fasting: An Interactive Mobile Time-Restricted Eating Diet Intervention for Patients With Brain Metastases to Maximize Radiation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Accrual rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (txt4fasting)
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.
干预措施: Behavioral Dietary Intervention (Behavioral)
Arm I (txt4fasting)
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.
干预措施: Text Message-Based Navigation Intervention (Other)
Arm I (txt4fasting)
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.
干预措施: Internet-Based Intervention (Other)
Arm I (txt4fasting)
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.
干预措施: Dietary Counseling and Surveillance (Behavioral)
Arm I (txt4fasting)
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.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm I (txt4fasting)
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.
干预措施: Biospecimen Collection (Procedure)
Arm I (txt4fasting)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm I (txt4fasting)
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.
干预措施: Neurocognitive Assessment (Other)
Arm I (txt4fasting)
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.
干预措施: Questionnaire Administration (Other)
Arm I (txt4fasting)
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.
干预措施: Interview (Other)
Arm II (attention control)
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.
干预措施: Internet-Based Intervention (Other)
Arm II (attention control)
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.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm II (attention control)
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.
干预措施: Text Message-Based Navigation Intervention (Other)
Arm II (attention control)
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.
干预措施: Biospecimen Collection (Procedure)
Arm II (attention control)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (attention control)
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.
干预措施: Neurocognitive Assessment (Other)
Arm II (attention control)
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.
干预措施: Questionnaire Administration (Other)
Arm II (attention control)
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.
干预措施: Interview (Other)
结局指标
主要结局
Accrual rate
时间窗: 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.
Time-restricted eating (TRE) compliance rate
时间窗: 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)
时间窗: Up to 6 months post intervention
AEs will be graded for severity according to the Common Terminology Criteria for Adverse Events.
Patient satisfaction
时间窗: 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.
Attrition rate
时间窗: 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.
次要结局
- Intracranial progression free survival (PFS)(Time between SRS to progression of brain metastases, assesed up to 6 months post intervention)
- Neurocognitive function decline(at 6 month follow up)
- Neurocognitive function decline(At baseline)
- Neurocognitive function decline(at the end of the 30-day intervention)
- Neurocognitive function decline(at 3 month follow up)