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Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients

Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05278260
Enrollment
24
Registered
2022-03-14
Start date
2022-05-25
Completion date
2024-11-13
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis Oral

Keywords

head and neck cancer, radiation therapy, supportive care

Brief summary

This study explores the effects of hydrogen-rich water on alleviating the radiation-induced acute mucositis in head and neck cancer patients

Interventions

DIETARY_SUPPLEMENTHydrogen tablets

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

DIETARY_SUPPLEMENTControl

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

Sponsors

DrinkHRW
CollaboratorUNKNOWN
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Number of participants who develop grade 3 oropharyngeal mucositis3 months after completing radiation therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026