What side effects are associated with this type of intervention?

Common treatments for oral mucositis with antioxidant properties include vitamin E and other antioxidants. Vitamin E, for instance, is generally well-tolerated but can cause side effects such as nausea, diarrhea, stomach cramps, fatigue, and blurred vision at high doses. Other antioxidants like glutamine, which is thought to reduce oxidative stress, may cause mild gastrointestinal symptoms. Overall, these treatments aim to reduce oxidative stress and inflammation, similar to the proposed mechanism of hydrogen-rich water.

What prior FDA approvals exist?

The FDA has approved several treatments for oral mucositis, particularly those that focus on reducing oxidative stress and inflammation. One notable example is palifermin (Kepivance), a recombinant human keratinocyte growth factor that helps protect and heal the mucosal lining. Additionally, amifostine (Ethyol) is used for its cytoprotective properties, reducing the severity of mucositis by scavenging free radicals and providing antioxidant effects. These treatments share a similar mechanism to hydrogen-rich water, which is being studied for its potential to alleviate radiation-induced mucositis through its antioxidant properties.

What other types of research exist?

Promising alternatives to Hydrogen-Rich Water for oral mucositis patients include omega-3 polyunsaturated fatty acids (n-3 PUFA) from fatty fish, vitamin C, and cherries due to their anti-inflammatory and antioxidant properties.

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Dietary Supplement

Hydrogen-rich Water for Mucositis

N/A

Recruiting

Led By Kartik Mani, MD

Research Sponsored by Clare Moran

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor

Planning to receive daily fractionated radiotherapy for over 4 weeks' duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include mild digestive discomfort or an unusual taste from the hydrogen tablets. Generally, hydrogen-rich water is considered safe with minimal risk of side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am scheduled for daily radiotherapy for more than 4 weeks.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Group II: ControlPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Oral Mucositis often involve the use of antioxidants, which work by reducing oxidative stress and inflammation—two major factors in the development of this condition. For instance, Hydrogen-Rich Water, which is being studied for its antioxidant properties, helps neutralize free radicals and decrease inflammatory responses. This mechanism is crucial for Oral Mucositis patients as it can protect the mucosal lining of the mouth from damage, thereby alleviating pain, reducing the risk of secondary infections, and improving the overall quality of life during cancer treatments.

Management of chemo/radiation-induced oral mucositis in patients with head and neck cancer: A review of the current literature.