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

Malignant Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175301
• Other study ID #: IRB2019-00236
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 31, 2019
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 31, 2025
• Est. primary completion date: July 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Drug:
• Hydrogen
Each hydrogen tablet contains 80 mg magnesium
• Placebo oral tablet
Matching placebo tablet also contains 80 mg magnesium

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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