Hydrogen-rich Water for Mucositis

Overseen By Caterina Vacchi-Suzzi, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Clare Moran

Compensation: Varies

Number of Visits: Unknown

Duration: Concurrent with radiation therapy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hydrogen-rich water can ease mouth sores caused by radiation treatment in individuals with head and neck cancer. Participants will receive either hydrogen tablets (producing hydrogen-rich water) or a placebo to compare effects. The trial seeks individuals diagnosed with head and neck cancer who are undergoing radiation therapy for more than four weeks and can eat and drink normally. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to explore this potential new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that hydrogen tablets are likely to be safe for humans?

In earlier studies, tests on animals have shown that hydrogen tablets are safe. However, detailed safety information for humans remains limited. Other research suggests that hydrogen-rich water might help reduce inflammation and speed up recovery, indicating potential safety for people. This trial is in its early stages and primarily focuses on assessing safety. So far, no strong evidence of serious side effects in humans has emerged. As this is an early phase trial, researchers continue to collect safety data. ^{1 2 3 4 5}

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

Unlike the standard treatments for mucositis, which often involve pain management and protective barriers, hydrogen-rich water introduces a new approach by using hydrogen tablets to potentially reduce inflammation and promote healing. Researchers are excited about this treatment because hydrogen has antioxidant properties that might neutralize harmful free radicals, which are believed to contribute to tissue damage in mucositis. This innovative method could offer a gentler, more natural option for patients, potentially minimizing the side effects associated with conventional medications.

What evidence suggests that hydrogen tablets might be an effective treatment for mucositis?

This trial will compare hydrogen-rich water (HRW) with a placebo to evaluate its effectiveness in easing mucositis symptoms. Research has shown that HRW might help with mucositis, a painful swelling often caused by radiation treatment. Studies have found that HRW can protect the stomach lining in animals and boost the body's natural defenses. One study discovered that inhaling hydrogen reduced inflammation and symptoms in people with radiation-related issues. Additionally, HRW has benefited liver damage in cancer patients receiving chemotherapy. These findings suggest that HRW could effectively reduce swelling and promote healing in mucositis. ^{1 2 3 5 6}

Who Is on the Research Team?

Kartik Mani, MD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for individuals with head and neck cancer, who are about to undergo daily radiotherapy for more than 4 weeks. Participants must be able to give consent, have a Karnofsky Performance Score of at least 70, swallow normally, and describe their pain.

Inclusion Criteria

Able to sign consent

I have been diagnosed with head and neck cancer, at any stage.

I can swallow food and water without any problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy for head and neck cancer

6-8 weeks

Treatment

Participants receive hydrogen-rich water to mitigate acute mucositis during radiation therapy

Concurrent with radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hydrogen tablets

Trial Overview The study is testing if drinking hydrogen-rich water can reduce mouth sores caused by radiation therapy in head and neck cancer patients. It compares the effects of regular water (control) with water containing dissolved hydrogen tablets.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Clare Moran

Lead Sponsor

Trials

1

Recruited

60+

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

DrinkHRW

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

Hydrogen-rich water (HRW) significantly reduced weight loss and disease activity in mice with inflammatory bowel disease (IBD), showing protective effects against colon damage and inflammation compared to the control group.

HRW treatment decreased oxidative stress and inflammatory markers while increasing protective indicators, suggesting its therapeutic potential in IBD through mechanisms involving the up-regulation of heme oxygenase-1 (HO-1) expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogen-rich water protects against inflammatory bowel disease in mice by inhibiting endoplasmic reticulum stress and promoting heme oxygenase-1 expression. Shen, NY., Bi, JB., Zhang, JY., et al.[2018]

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]

Hydrogen-rich water (HRW) significantly reduced gastric mucosal damage caused by aspirin in rats, as evidenced by lower damage scores and improved oxidative stress markers.

HRW pretreatment decreased inflammation and COX-2 expression in gastric tissues, suggesting it protects against aspirin-induced gastric injury by inhibiting oxidative stress and inflammatory responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective role of hydrogen-rich water on aspirin-induced gastric mucosal damage in rats. Zhang, JY., Wu, QF., Wan, Y., et al.[2021]

Hydrogen-rich water (HRW) significantly reduced intestinal damage and inflammation caused by the NSAID indomethacin in mice, indicating its potential as a therapeutic agent for NSAID-induced enteropathy.

HRW treatment increased the levels of short-chain fatty acids (SCFAs) in the gut, which may contribute to its protective effects, while also reducing oxidative stress and inflammatory cytokines associated with intestinal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ameliorating Role of Hydrogen-Rich Water Against NSAID-Induced Enteropathy via Reduction of ROS and Production of Short-Chain Fatty Acids. Akita, Y., Higashiyama, M., Kurihara, C., et al.[2023]

Hydrogen has been identified as a powerful antioxidant and anti-inflammatory agent, suggesting its potential for therapeutic use in various medical applications.

Among the different methods of hydrogen administration, drinking hydrogen-rich solutions may be the most practical and suitable for daily use, making it a promising option for patients in emergency and critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of experimental studies of hydrogen as a new therapeutic agent in emergency and critical care medicine. Shen, M., Zhang, H., Yu, C., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05278260

Hydrogen-rich Water and Treatment of Mucositis Caused ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10707987/

Molecular Hydrogen Therapy—A Review on Clinical Studies ... A study with 134 colorectal cancer patients found that hydrogen-rich water can alleviate mFOLFOX6 chemotherapy-induced liver injuries [36]. Non- ...

3. withpower.com withpower.com/trial/early-phase-1-mucositis-oral-5-2022-1726c

Hydrogen-rich Water for Mucositis · Info for Participants Hydrogen-rich water (HRW) significantly reduced gastric mucosal damage caused by aspirin in rats, as evidenced by lower damage scores and improved oxidative ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4699099/

Hydrogen-Rich Water Intake Accelerates Oral Palatal ... These data suggest that hydrogen-rich water intake promoted the upregulation of the expression of antioxidant defense genes by activating the Nrf2 pathway.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001666

Clinical Efficacy of Hydrogen Therapy on Acute Radiation ... Hydrogen inhalation is a safe and effective adjunctive therapy that significantly alleviates inflammation and mitigates clinical symptoms of ARE in patients ...

6. webmd.com webmd.com/diet/hydrogen-water-health-benefits

Hydrogen Water: Health Benefits and Side Effects Hydrogen water is said to increase energy, reduce inflammation, and reduce recovery times after workouts.