NCT05278260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

March 3, 2022

Last Update Submit

May 12, 2025

Conditions

Mucositis Oral

Keywords

head and neck cancerradiation therapysupportive care

Outcome Measures

Primary Outcomes (1)

  • Number of participants who develop grade 3 oropharyngeal mucositis

    3 months after completing radiation therapy

Study Arms (2)

Control

PLACEBO COMPARATOR
Dietary Supplement: Control

Active

EXPERIMENTAL
Dietary Supplement: Hydrogen tablets

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

Active
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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

StomatitisHead and Neck Neoplasms

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Study Officials

  • Kartik Mani, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Survivorship Program Coordinator - Department of Radiation Oncology

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

May 25, 2022

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)