Glioblastoma, IDH-Wildtype, WHO Grade 4 Glioma
Conditions
Brief summary
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.
Interventions
OTHERBest Practice
Receive SOC treatment
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHERDietary Intervention
Attend dietary counseling sessions
OTHERGlucose Measurement
Undergo intermittent glucose monitoring
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
OTHERMonitoring
Undergo CGM
OTHERQuestionnaire Administration
Ancillary studies
OTHERSupportive Care
Receive endocrinology-guided interventions
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
To reduce bias, all imaging and quality of life assessments will be interpreted by evaluators blinded to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival at 12 months | At 12 months | Defined as the time from study enrollment until death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - EORTC QLQ C-30 | At 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-BN20 | At 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. |
| Incidence of symptomatic hypoglycemia | Up 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. |
| Fasting glucose | 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Outcome results
None listed