Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University

Criteria

Inclusion Criteria:

• Aged 18 years old or over

• New diagnosis of a malignant glioma (HGG) either by a biopsy or craniotomy

• KPS of at least 70

• Being able to fill out quality of life questionnaire

Exclusion Criteria:

• Other major diseases of the central nervous system, including history of prior brain tumors, Alzheimer's disease, Parkinson's disease, demyelinating disease, inflammatory brain or vascular disease, traumatic encephalopathy, or idiopathic intracranial hypertension, anxiety/depression.

• Pre-existing neurological disability, unable to read or write

• Severe comorbidities likely to result in patient dying within 3 months

• Prior history of head/neck radiation therapy

• Other active cancer or history of other cancer diagnosed within 5 year.

• Inability to safely tolerate the 1500 ml- 2000ml fluid load (po water) associated with study medication*

• Pregnancy or nursing.

• Treatment with another investigational drug within the last 30 days that may interfere with this study's medications*

• Hypersensitivity to Temozolomide and or it's active agent- Dacarbazine