Best Practice
OtherReceive SOC treatment
Other names: standard of care, standard therapy
NCT Number: NCT07091864
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mayo Clinic in Arizona, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive SOC treatment
Other names: standard of care, standard therapy
Undergo blood sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Attend dietary counseling sessions
Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Undergo intermittent glucose monitoring
Other names: GLUC, Glucose
Undergo MRI
Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo CGM
Other names: monitor
Ancillary studies
Receive endocrinology-guided interventions
Other names: Supportive Therapy, Symptom Management, Therapy, Supportive
Time frame: At 12 months
Defined as the time from study enrollment until death due to any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Phase II Randomized Trial Of Glucose Monitoring In Glioblastoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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