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

NCT04175301 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB2019-00236
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Glioma

Keywords

neuroprotection; hydrogen; antioxidant; malignant glioma

Outcome Measures

Primary Outcomes (1)

• Patient enrollment statistics

  Feasibility of recruitment, assessment procedures, treatment, and outcome measures will be evaluated. Number of screened / eligible / enrolled patients, treatment adherence, assessment completion, subject dropout, data completeness, and data variability.

  3 years

Secondary Outcomes (5)

• European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score

  2 years

• European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score

  2 years

• Memory

  2 years

• Karnofsky performance score (KPS)

  2 years

• Overall survival and progression free survival (PFS)

  2 years

Study Arms (2)

Hydrogen

EXPERIMENTAL

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.

Drug: Hydrogen

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo oral tablet

Interventions

Hydrogen DRUG

Each hydrogen tablet contains 80 mg magnesium

Also known as: H2

Hydrogen

Placebo oral tablet DRUG

Matching placebo tablet also contains 80 mg magnesium

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794-8121, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• Agnieszka Kowalska, MD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects will be randomly assigned in a 2:1 ratio to receive hydrogen or placebo, additionally to all standard-of-care treatments by the SB Research Pharmacy. Masking of active and placebo treatments will be preserved by creating study medication containers that appear identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 25, 2019
• Study Start: October 31, 2019
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)