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

Stony Brook University

Status and phase: Completed; Early Phase 1

Conditions: Mucositis Oral

Treatments: Dietary Supplement: Control; Dietary Supplement: Hydrogen tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05278260

SBU-HYDROGEN-HN-RT

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Dietary Supplement: Control

Active

Experimental group

Treatment:

Dietary Supplement: Hydrogen tablets