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Completed

NCT Number: NCT05278260

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

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

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Key information

Conditions

Mucositis Oral Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Hydrogen tablets

Dietary 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

Control

Dietary 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

Primary outcomes

  1. Number of participants who develop grade 3 oropharyngeal mucositis

    Time frame: 3 months after completing radiation therapy

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • DrinkHRW

Registry information

Official study title

Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2022
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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