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| ID | Type | Description | Link |
|---|---|---|---|
| 25-006112 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (SOC, CGM) | Experimental | 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. |
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| Arm B (SOC, intermittent glucose monitoring) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive SOC treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival at 12 months | Defined as the time from study enrollment until death due to any cause. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic hypoglycemia | 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. | Up to 52 weeks |
| Quality of Life - EORTC QLQ C-30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gelareh Zadeh, MD, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Not yet recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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To reduce bias, all imaging and quality of life assessments will be interpreted by evaluators blinded to group assignment.
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Dietary Intervention | Other | Attend dietary counseling sessions |
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| Glucose Measurement | Other | Undergo intermittent glucose monitoring |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Monitoring | Other | Undergo CGM |
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| Questionnaire Administration | Other | Ancillary studies |
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| Supportive Care | Other | Receive endocrinology-guided interventions |
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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. |
| At baseline, 3 months, 6 months, and 12 months |
| Quality of Life - EORTC QLQ-BN20 | 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. | At baseline, 3 months, 6 months, and 12 months |
| Hemoglobin (HbA1c) | 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. | At 3 months, 6 months, and 12 months |
| Fasting glucose | Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used. | At 3 months, 6 months, and 12 months |
| Lactate levels (continuous) | Compared at 3, 6 and 12 months using repeated measures mixed models. Random intercept will be used. | At 3 months, 6 months, and 12 months |
| Mayo Clinic in Florida | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| D004035 | Diet Therapy |
| D005947 | Glucose |
| D009682 | Magnetic Resonance Spectroscopy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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