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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Glioma

Intervention / Treatment
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* Drug: Hydrogen
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen<br>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<br>* Each hydrogen tablet contains 80 mg magnesium<br>* Other names: H2;|
| Placebo Comparator: Placebo<br>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<br>* Matching placebo tablet also contains 80 mg magnesium<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroprotection, hydrogen, antioxidant, malignant glioma