Mucositis OralEarly Phase 1NCT05278260
Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients
A Early Phase 1 study testing Hydrogen tablets in people with Mucositis Oral, run by Stony Brook University at 1 site in United States.
Trial summary
This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- Hydrogen tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 13 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Karnofsky Performance Score (KPS) of at least 70
- Able to describe pain
- Able to swallow food and water
- Able to sign consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook Cancer Center
Stony Brook, New York, 11794
About this study
Official title: Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy
This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients
- Conditions
- Mucositis Oral
- Being tested
- Hydrogen tablets, Control
- Keywords
- head and neck cancer, radiation therapy, supportive care
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen tabletsDietary supplement
Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that releases molecular hydrogen, for the duration of the radiation therapy
ControlDietary supplement
Participants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that does not release any molecular hydrogen, for the duration of the radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
| Active | Experimental | Not described Receives: Dietary Supplement: Hydrogen tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop grade 3 oropharyngeal mucositis
Measured: 3 months after completing radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start25 May 2022
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- DrinkHRW
- Responsible party
- Principal investigator, Clare Moran, Stony Brook University
- Investigators
- Kartik Mani, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278260
- Sponsor's protocol ID
- SBU-HYDROGEN-HN-RT
- Status last verified
- May 2025
- First submitted
- 3 Mar 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy
- ClinicalTrials.gov ID
- NCT05278260
- Acronym / sponsor ID
- SBU-HYDROGEN-HN-RT
- Conditions
- Mucositis Oral
- Keywords
- head and neck cancer, radiation therapy, supportive care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- DrinkHRW
- Study start
- 25 May 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control |
| Active | Experimental | Dietary Supplement: Hydrogen tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Karnofsky Performance Score (KPS) of at least 70
- Able to describe pain
- Able to swallow food and water
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen tabletsParticipants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that releases molecular hydrogen, for the duration of the radiation therapy | Dietary supplement | Active |
| ControlParticipants will drink up to 1000 ml (34 fl. oz.) of water daily supplemented with a tablet that does not release any molecular hydrogen, for the duration of the radiation therapy | Dietary supplement | Control |
Primary outcome
Number of participants who develop grade 3 oropharyngeal mucositis
Time frame: 3 months after completing radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Mani, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrogen tablets in people with Mucositis Oral, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who develop grade 3 oropharyngeal mucositis (time frame: 3 months after completing radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.