Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Overall survival at 12 months
研究概览
简要总结
This clinical trial studies whether continuous glucose monitoring (CGM) can be used to help patients with glioblastoma manage their blood sugar (glucose) levels and improve survival. Glioblastoma is the most common malignant primary brain tumor in adults, with an average survival time of approximately 15-18 months despite therapy. Studies have shown that having a higher-than-normal amount of glucose in the blood (hyperglycemia) during radiation therapy is associated with poorer survival outcomes in glioblastoma patients. Hyperglycemia in glioblastoma patients is often driven by steroids that are commonly used during treatment. CGM uses a device that places a sensor under the skin that monitors glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This can help to identify when a patient has changes in their glucose levels so they may receive necessary interventions or medications sooner. CGM may be an effective way for glioblastoma patients to manage their glucose levels, which may improve survival.
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
- Single (Outcomes Assessor)
盲法说明
To reduce bias, all imaging and quality of life assessments will be interpreted by evaluators blinded to group assignment.
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
- •Presumed newly diagnosed GBM based on imaging findings consistent with GBM on brain MRI (e.g., heterogeneously enhancing mass with central necrosis and surrounding edema), as determined by the treating neuro-oncology team
- •Age ≥ 18 years at the time of consent
- •Negative serum pregnancy test within 7 days prior to registration for individuals of childbearing potential
- •Karnofsky performance status (KPS) ≥ 70 at baseline
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (performed within 14 days prior to registration)
- •Platelet count ≥ 100 × 10^9/L (performed within 14 days prior to registration)
- •Hemoglobin ≥ 9 g/dL (performed within 14 days prior to registration)
- •Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (performed within 14 days prior to registration)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (performed within 14 days prior to registration)
- •Total bilirubin ≤ 1.5 × ULN (performed within 14 days prior to registration)
- •Willingness and ability to comply with CGM device use and attend dietary counseling sessions as per standard of care
排除标准
- •Recurrent glioblastoma
- •History of eating disorders (e.g., anorexia nervosa, bulimia) or substance use disorder within the past 12 months
- •Any other uncontrolled or inadequately managed medical illness (e.g., unstable cardiovascular, hepatic, renal, or psychiatric condition) that, in the opinion of the investigator, would interfere with study participation or interpretation of results
- •Concurrent diagnosis of another active malignancy requiring treatment
- •Pregnancy or breastfeeding at the time of registration
- •Documented history of type 1 diabetes mellitus
研究组 & 干预措施
Arm B (SOC, intermittent glucose monitoring)
Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm B (SOC, intermittent glucose monitoring)
Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm B (SOC, intermittent glucose monitoring)
Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Glucose Measurement (Other)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Supportive Care (Other)
Arm B (SOC, intermittent glucose monitoring)
Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Best Practice (Other)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Best Practice (Other)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Dietary Intervention (Other)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Monitoring (Other)
Arm A (SOC, CGM)
Patients receive SOC treatment plus CGM with endocrinology-guided interventions as needed and attend dietary counseling sessions once a month for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm B (SOC, intermittent glucose monitoring)
Patients receive SOC treatment plus intermittent glucose monitoring as clinically indicated for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI throughout the trial.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Overall survival at 12 months
时间窗: At 12 months
Defined as the time from study enrollment until death due to any cause.
次要结局
- Incidence of symptomatic hypoglycemia(Up to 52 weeks)
- Quality of Life - EORTC QLQ C-30(At baseline, 3 months, 6 months, and 12 months)
- Quality of Life - EORTC QLQ-BN20(At baseline, 3 months, 6 months, and 12 months)
- Hemoglobin (HbA1c)(At 3 months, 6 months, and 12 months)
- Fasting glucose(At 3 months, 6 months, and 12 months)
- Lactate levels (continuous)(At 3 months, 6 months, and 12 months)