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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates if drinking hydrogen-rich water can help head and neck cancer patients who have painful mouth sores from radiation therapy by reducing inflammation and pain.

Will I have to stop taking my current medications?

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

How is hydrogen-rich water different from other treatments for mucositis?

Hydrogen-rich water is unique because it acts as a potent antioxidant and anti-inflammatory agent, which may help protect and heal tissues by reducing oxidative stress and inflammation. Unlike other treatments, it is administered by drinking water infused with molecular hydrogen, making it a practical and non-invasive option. ^{1 2 3 4 5}

Research Team

Kartik Mani, MD

Principal Investigator

Stony Brook University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

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

Protective role of hydrogen-rich water on aspirin-induced gastric mucosal damage in rats. [2021]

2. United States 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. [2018]

3. China pubmed.ncbi.nlm.nih.gov

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

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

A review of experimental studies of hydrogen as a new therapeutic agent in emergency and critical care medicine. [2018]

5. United States 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. [2023]