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

Stony Brook University

Status and phase: Active, not recruiting; Phase 2

Conditions: Malignant Glioma

Treatments: Drug: Hydrogen; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04175301

IRB2019-00236

Details and patient eligibility

About

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.

Full description

This will be a pilot trial exploring the ability of molecular hydrogen to improve quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide. Hydrogen has an excellent safety profile, has antioxidant properties and reduces inflammatory events in the tissues. It has been postulated in previous studies that continuous consumption of hydrogen water reduces oxidative stress in the brain by lowering the concentration of the reactive oxygen species, resulting in the improvement of adult neurogenesis or the stimulation of neural proliferation, leading to the prevention of the decline in the learning and memory.

This will be a double blinded, placebo-controlled trial. Eligible and willing subjects will be randomly assigned in a 2:1 ratio to be treated with either hydrogen or placebo, to receive hydrogen or placebo, additionally to all standard-of-care treatments. The treatment with hydrogen or placebo will start the day before chemoradiation therapy starts, and continue for six weeks. The effects of drinking hydrogen water on the quality of life will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-BN20 questionnaires at baseline, at 6 weeks, 6 months, 12 months, 18 months and 24 months.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Hydrogen

Experimental group

Description:

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.

Treatment:

Drug: Hydrogen

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet