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NCT05278260 Clinical Trial

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

Mucositis Oral Clinical Trial

Official title:
Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05278260
Other study ID # SBU-HYDROGEN-HN-RT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date September 2024

Study information
Verified date October 2023
Source Stony Brook University
Contact Clare Moran, NP
Phone (631) 444-2210
Email Clare.Moran@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Hydrogen 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
• Control
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

Locations
Country Name City State
United States Stony Brook Cancer Center Stony Brook New York

Sponsors (2)
Lead Sponsor Collaborator
Stony Brook University DrinkHRW

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who develop grade 3 oropharyngeal mucositis 3 months after completing radiation therapy
See also
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