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

NCT ID: NCT05278260

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-11-13

Brief Summary

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

Detailed Description

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Conditions

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Mucositis Oral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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

Active

Group Type EXPERIMENTAL

Hydrogen tablets

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DrinkHRW

UNKNOWN

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Clare Moran

Survivorship Program Coordinator - Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kartik Mani, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook Cancer Center

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SBU-HYDROGEN-HN-RT

Identifier Type: -

Identifier Source: org_study_id

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