Trial Summary
What is the purpose of this trial?This is a pilot randomized control trial (RCT) to explore the effects of hydrogen rich water on quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide.
Eligibility Criteria
Adults over 18 with a new diagnosis of high-grade malignant glioma, able to perform daily activities (KPS ≥70), and can complete quality of life surveys. Excluded are those with neurological disabilities, inability to handle increased fluid intake, pregnant or nursing women, allergies to Temozolomide/Dacarbazine, prior brain treatments or major CNS diseases, severe other illnesses, active cancers or recent cancer history.Inclusion Criteria
Being able to fill out quality of life questionnaire
I am 18 years old or older.
I have been newly diagnosed with a high-grade glioma through a biopsy or surgery.
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Exclusion Criteria
Treatment with another investigational drug within the last 30 days that may interfere with this study's medications
I have had radiation therapy for my head or neck in the past.
Severe comorbidities likely to result in patient dying within 3 months
+6 more
Participant Groups
The trial is testing if drinking hydrogen-rich water improves the quality of life for patients undergoing radiation and chemotherapy (Temozolomide) for high-grade brain tumors. It's a pilot study where participants are randomly assigned to receive either hydrogen water or a placebo.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydrogenExperimental Treatment1 Intervention
Five times per day for 6 weeks subjects will dissolve a hydrogen generating tablet into water and drink the effervescent water. Dissolving one tablet in 250 mL of water will achieve a saturating hydrogen concentration of approximately 1.6 ppm.
Group II: PlaceboPlacebo Group1 Intervention
Five times per day for 6 weeks subjects will dissolve an placebo tablet into water and drink the effervescent water. The effervescent placebo tablet does not generate hydrogen-enriched water.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stony Brook University Medical CenterStony Brook, NY
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Who Is Running the Clinical Trial?
Stony Brook UniversityLead Sponsor