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

Early Phase 1CompletedNCT05278260

Stony Brook University24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Mucositis Oral

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Stony Brook Cancer Center

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Number of participants who develop grade 3 oropharyngeal mucositis

Time frame: 3 months after completing radiation therapy

Data from ClinicalTrials.gov

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