Malignant GliomaPhase 2NCT04175301
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
A Phase 2 study testing Hydrogen in people with Malignant Glioma, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Hydrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794-8121
About this study
Official title: 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.
Read the 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.
- Conditions
- Malignant Glioma
- Being tested
- Hydrogen, Placebo oral tablet
- Keywords
- neuroprotection, hydrogen, antioxidant, malignant glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrogenDrug
Also called H2
Each hydrogen tablet contains 80 mg magnesium
Placebo oral tabletDrug
Matching placebo tablet also contains 80 mg magnesium
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start31 Oct 2019
- Primary completion5 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Kowalska, Stony Brook University
- Investigators
- Agnieszka Kowalska, MD, Principal investigator, Stony Brook Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175301
- Sponsor's protocol ID
- IRB2019-00236
- Status last verified
- Jul 2025
- First submitted
- 20 Nov 2019
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.
- ClinicalTrials.gov ID
- NCT04175301
- Acronym / sponsor ID
- IRB2019-00236
- Conditions
- Malignant Glioma
- Keywords
- neuroprotection, hydrogen, antioxidant, malignant glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen | Experimental | Drug: HydrogenFive 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. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletFive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrogenAlso: H2Each hydrogen tablet contains 80 mg magnesium | Drug | Hydrogen |
| Placebo oral tabletMatching placebo tablet also contains 80 mg magnesium | Drug | Placebo |
Primary outcome
Patient enrollment statistics
Time frame: 3 years
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.
5 secondary outcomes
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score
Time frame: 2 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score
Time frame: 2 years
Memory
Time frame: 2 years
Karnofsky performance score (KPS)
Time frame: 2 years
Overall survival and progression free survival (PFS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Kowalska, MD principal investigator
Stony Brook Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogen in people with Malignant Glioma, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment statistics (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.