Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT07091864

Reclutamiento

Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma

Intervencionista

Fase no especificada

Mayo Clinic in Rochester

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.

Categoría de tratamiento

Procedimiento, Otros

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2025-07-29

Última actualización por el patrocinador

2025-11-10

Finalización estimada

2027-11-30

Elegibilidad

Criterios de inclusión

* 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

* Karnofsky performance status (KPS) ≥ 70 at baseline

* Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L

* Platelet count ≥ 100 × 10^9/L

* Hemoglobin ≥ 9 g/dL

* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min

* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN

* Total bilirubin ≤ 1.5 × ULN

* Willingness and ability to comply with CGM device use and attend dietary counseling sessions as part of the study protocol

Criterios de exclusión

* Recurrent glioblastoma or prior therapy for glioblastoma beyond surgical resection or biopsy

* 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 enrollment

* Documented history of type 1 diabetes mellitus

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Detalles del diseño

AsignaciónRandomized

Modelo de intervenciónParallel Assignment

EnmascaramientoSingle

Número a inscribir116

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: 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.

Intervenciones:

Biospecimen Collection
Magnetic Resonance Imaging
Questionnaire Administration
Best Practice
Dietary Intervention
Glucose Measurement
Monitoring
Supportive Care

Medidas de resultado

Medidas de resultado primarias

Overall survival at 12 monthsAt 12 months

Defined as the time from study enrollment until death due to any cause.

Medidas de resultado secundarias

Incidence of symptomatic hypoglycemiaUp to 52 weeks

Will be defined as continuous glucose monitoring glucose < 70 mg/dL with concurrent symptoms. Proportion of participants with ≥ 1 symptomatic hypoglycemia event will be analyzed with Fisher's exact test.

Quality of Life - EORTC QLQ C-30At baseline, 3 months, 6 months, and 12 months

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.

Quality of Life - EORTC QLQ-BN20At baseline, 3 months, 6 months, and 12 months

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 is a 20-item questionnaire related to symptoms experienced by patients with brain cancer during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2=a little; 3-quite a bit; and 4=very much. Higher scores indicate greater severity of symptoms.

Hemoglobin (HbA1c)At 3 months, 6 months, and 12 months

Compared at 3, 6 and 12 months using repeated measures mixed models. Model based contrasts will be used to estimate the between group changes from baseline in A1c values. Random intercept will be used.

Fasting glucoseAt 3 months, 6 months, and 12 months

Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.

Lactate levels (continuous)At 3 months, 6 months, and 12 months

Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used.

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Mayo Clinic in Rochester
Rochester, Minnesota, US

Reclutando

Rochester, Minnesota, 55905 US

Mayo Clinic in Rochester

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