Hydrogen Rich Water for Brain Cancer

Overseen By Agnieszka Kowalska, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stony Brook University

Must be taking: Temozolomide

Must not be taking: Investigational drugs

Disqualifiers: Alzheimer's, Parkinson's, other cancers, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking another investigational drug, you must have stopped it at least 30 days before joining this study.

How does hydrogen-rich water treatment differ from other brain cancer treatments?

Hydrogen-rich water is unique because it uses molecular hydrogen, known for its antioxidant and anti-inflammatory properties, to potentially treat brain cancer. Unlike traditional treatments, it is non-invasive and may offer benefits by reducing inflammation and oxidative stress, which are linked to cancer progression. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Hydrogen Rich Water for Brain Cancer?

Research suggests that hydrogen, as an antioxidant, may help control cancer progression and improve quality of life in advanced cancer patients. In studies, hydrogen inhalation showed potential in reducing tumor growth and improving survival in glioblastoma, a type of brain cancer, in animal models. ^{3 4 6 7 8}

Who Is on the Research Team?

Agnieszka Kowalska, MD

Principal Investigator

Stony Brook Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Being able to fill out quality of life questionnaire

I have been newly diagnosed with a high-grade glioma through a biopsy or surgery.

I am mostly able to care for myself but may not be able to do active work.

Exclusion Criteria

Treatment with another investigational drug within the last 30 days that may interfere with this study's medications

I have had radiation therapy for my head or neck in the past.

Severe comorbidities likely to result in patient dying within 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hydrogen or placebo water five times per day for 6 weeks, concurrent with chemoradiation therapy

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for quality of life, memory, and performance scores at multiple intervals

24 months

Visits at 6 weeks, 6 months, 12 months, 18 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Hydrogen
• Placebo oral tablet

Trial Overview 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.

How Is the Trial Designed?

Group I: Hydrogen Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Published Research Related to This Trial

Hydrogen-rich water (HRW) combined with the chemotherapy agent 5-fluorouracil (5-FU) significantly reduced tumor weight and size in a mouse model of colorectal cancer, suggesting a potential new therapeutic approach.

HRW appears to counteract the oxidative stress caused by 5-FU, enhancing antioxidant activity and improving treatment outcomes compared to 5-FU alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogen-rich water exerts anti-tumor effects comparable to 5-fluorouracil in a colorectal cancer xenograft model. Asgharzadeh, F., Tarnava, A., Mostafapour, A., et al.[2022]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

"Real world survey" of hydrogen-controlled cancer: a follow-up report of 82 advanced cancer patients. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Antitumoral Activity of Molecular Hydrogen and Proton in the Treatment of Glioblastoma: An Atypical Pharmacology? [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

A narrative review of hydrogen oncology: from real world survey to real world evidence. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Effects of drinking hydrogen-rich water on the quality of life of patients treated with radiotherapy for liver tumors. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Hydrogen-rich water exerts anti-tumor effects comparable to 5-fluorouracil in a colorectal cancer xenograft model. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Neutral pH hydrogen-enriched electrolyzed water achieves tumor-preferential clonal growth inhibition over normal cells and tumor invasion inhibition concurrently with intracellular oxidant repression. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Hydrogen-rich water ameliorates neuropathological impairments in a mouse model of Alzheimer's disease through reducing neuroinflammation and modulating intestinal microbiota. [2023]