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

Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Glioma
• Intervention / Treatment: Drug: Hydrogen; Drug: Placebo oral tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christine Pol, PhD; Phone Number: 6314449083; Email: christiana.pol@stonybrookmedicine.edu
• Study Contact Backup: Name: Agnieszka Kowalska, MD; Phone Number: 631-444-2599; Email: agnieszka.kowalska@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794-8121
      • Stony Brook University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogen; 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; Each hydrogen tablet contains 80 mg magnesium; Other Names: H2
Placebo Comparator: Placebo; 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; Matching placebo tablet also contains 80 mg magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score	Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-C30 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	2 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score	Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-BN20 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	2 years
Memory	Change in memory from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the Mini-Mental State Examination (MMSE).	2 years
Karnofsky performance score (KPS)	Change in Karnofsky performance score (KPS) from baseline to week 6, month 6, month 12, month 18, and month 24.	2 years
Overall survival and progression free survival (PFS)	Overall survival is defined as the time from randomization until death from any cause. PFS is defined as the time from randomization until tumor progression (defined by McDonald's criteria).	2 years

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Agnieszka Kowalska, MD, Stony Brook Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Estimated): July 5, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: malignant glioma; neuroprotection; antioxidant; hydrogen
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: IRB2019-00236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No