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Hydrogen Rich Water for Brain Cancer

Phase 2
Waitlist Available
Led By Agnieszka Kowalska, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years old or over
New diagnosis of a malignant glioma (HGG) either by a biopsy or craniotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will explore whether hydrogen rich water can improve quality of life for brain cancer patients undergoing radiation and chemotherapy.

Who is the study for?
Adults over 18 with a new diagnosis of high-grade malignant glioma, able to perform daily activities (KPS ≥70), and can complete quality of life surveys. Excluded are those with neurological disabilities, inability to handle increased fluid intake, pregnant or nursing women, allergies to Temozolomide/Dacarbazine, prior brain treatments or major CNS diseases, severe other illnesses, active cancers or recent cancer history.Check my eligibility
What is being tested?
The trial is testing if drinking hydrogen-rich water improves the quality of life for patients undergoing radiation and chemotherapy (Temozolomide) for high-grade brain tumors. It's a pilot study where participants are randomly assigned to receive either hydrogen water or a placebo.See study design
What are the potential side effects?
Potential side effects from the intervention itself may be minimal as it involves consuming hydrogen-rich water; however, associated treatments like radiotherapy and chemotherapy could cause fatigue, nausea, headaches and other common side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been newly diagnosed with a high-grade glioma through a biopsy or surgery.
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I am mostly able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient enrollment statistics
Secondary outcome measures
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score
Karnofsky performance score (KPS)
+2 more

Side effects data

From 2019 Phase 2 & 3 trial • 15 Patients • NCT03320018
17%
headache
17%
petechial hemorrhagic stroke conversion
17%
hyponatremia
17%
diarrhea
17%
increased BUN/creatinine
17%
stroke
17%
bradycardia and syncope
17%
thrombus
17%
hypotension
17%
rash
17%
bradycardia
17%
black lesion in foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hydrogen/Minocycline
Placebo Hydrogen/Placebo Minocycline

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydrogenExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrogen
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,512 Total Patients Enrolled
Agnieszka Kowalska, MDPrincipal Investigator - Stony Brook Medicine
Stony Brook University Medical Center
Ross University (Medical School)
University Hosp-Suny Stony Brook (Residency)
1 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Hydrogen Clinical Trial Eligibility Overview. Trial Name: NCT04175301 — Phase 2
Malignant Glioma Research Study Groups: Hydrogen, Placebo
Malignant Glioma Clinical Trial 2023: Hydrogen Highlights & Side Effects. Trial Name: NCT04175301 — Phase 2
Hydrogen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175301 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other investigations that have focused on Hydrogen?

"Currently, 10 trials are underway to assess the efficacy of Hydrogen. Notably, 4 of these have entered phase III while 490 different sites are enrolling participants. The majority of locations can be found in Bethesda, Maryland."

Answered by AI

Is enrollment still open for this experiment?

"Affirmative. According to information on clinicaltrials.gov, the study is still recruiting participants since its posting date of October 31st 2019 and last update on November 8th 2022. The trial requires 15 individual enrollees at 1 medical centre."

Answered by AI

Has Hydrogen attained regulatory sanction from the FDA?

"Hydrogen's safety is tentatively rated at 2, since this Phase 2 trial has minimal evidence for efficacy but some data regarding its security."

Answered by AI

How many participants are being accepted into this research endeavor?

"Affirmative. Clinicaltrials.gov displays that recruitment for this experiment is ongoing, having been initially posted on October 31st 2019 and edited most recently on November 8th 2022. The research requires 15 participants from a single clinical centre to be enrolled."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
Agnieszka Kowalska 2019. "Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175301.
~3 spots leftby Jul 2025
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