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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hydrogen-rich water can improve the quality of life for people with high-grade gliomas, a type of brain cancer. Participants will drink either water with hydrogen tablets or a placebo (a tablet with no active ingredients) over six weeks while undergoing radiation and chemotherapy. It is ideal for individuals newly diagnosed with malignant glioma who can complete a quality-of-life survey and are currently receiving specific cancer treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hydrogen-rich water is generally safe for use. Studies have found that hydrogen at therapeutic levels does not cause major health problems. For instance, research on hydrogen therapy, including drinking water with added hydrogen, indicates it is safe for the body. These studies have reported no major side effects, although maintaining the right amount of hydrogen in the water can be challenging due to its tendency to escape over time. Overall, based on current research, hydrogen-rich water appears to be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about hydrogen-rich water as a treatment for brain cancer because it's an innovative approach that differs from traditional therapies like surgery, radiation, and chemotherapy. This treatment leverages a new active ingredient—hydrogen—which is delivered in a unique way by dissolving a tablet in water to create hydrogen-enriched water that patients drink. The potential benefits of hydrogen, such as its antioxidant properties, could provide a less invasive and more tolerable option for patients. Unlike conventional treatments that often come with severe side effects, hydrogen-rich water might offer a gentler alternative with fewer adverse effects.

What evidence suggests that hydrogen rich water might be an effective treatment for brain cancer?

This trial will compare hydrogen-rich water with a placebo for brain cancer patients. Research has shown that hydrogen-rich water might benefit brain cancer patients. One study found that inhaling hydrogen slowed brain tumor growth in mice and extended their lifespan. In humans, inhaling a hydrogen and oxygen mix reduced brain swelling after surgery in glioma patients. A review of various studies also indicates that hydrogen therapy might help manage cancer by reducing damage from free radicals. These findings suggest that hydrogen-rich water could improve outcomes for brain cancer patients when combined with traditional treatments. ^{3 5 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. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1413904/full

Effects of perioperative hydrogen inhalation on brain ... Discussion: In conclusion, hydrogen/oxygen inhalation effectively reduced postoperative brain edema in glioma patients. Further research is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10152878/

A Systematic Review of Molecular Hydrogen Therapy in ... This review summarises the findings from various articles on the mechanism, treatment outcomes, and overall effectiveness of H2 therapy on cancer management.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6528353/

Molecular hydrogen suppresses glioblastoma growth via ... The in vivo study showed that hydrogen inhalation could effectively suppress GBM tumor growth and prolong the survival of mice with GBM.

4. mdpi.com mdpi.com/2076-3921/14/8/948

Long-Term Neuroprotective Effects of Hydrogen-Rich ... Despite its therapeutic efficacy, brain irradiation often results in progressive cognitive impairment, affecting 50–90% of long-term survivors [2]. These ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405580825000202

A comprehensive review of molecular hydrogen as a novel ... Over the past two decades, numerous biomedical reports have revealed the therapeutic benefits of molecular hydrogen (H2) in relieving oxidation-related diseases ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10816294/

Hydrogen Water: Extra Healthy or a Hoax?—A Systematic ... The benefits of hydrogen use have been evaluated in conditions such as cardiac fibrosis, neuronal disease, hepatic injury, radiation-induced disease, diabetes, ...

7. mdpi.com mdpi.com/2076-3425/13/8/1168

Antitumoral Activity of Molecular Hydrogen and Proton in ... Experimental data indicate that H2 is an antitumor agent in the treatment of glioblastoma (GBM). In vivo H2 inhalation could suppress the growth of GBM tumors.

8. hue-light.com hue-light.com/blog/hydrogen-therapy-for-cancer/

Hydrogen Therapy for Cancer: Evidence, Benefits & Safety At therapeutic concentrations, molecular hydrogen is considered biologically safe. In 2007, researchers discovered that hydrogen acts as a ...