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

Primary Purpose

Mucositis Oral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrogen tablets
Control
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mucositis Oral focused on measuring head and neck cancer, radiation therapy, supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

-

Sites / Locations

  • Stony Brook Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Active

Arm Description

Outcomes

Primary Outcome Measures

Number of participants who develop grade 3 oropharyngeal mucositis

Secondary Outcome Measures

Full Information

First Posted
March 3, 2022
Last Updated
October 13, 2023
Sponsor
Stony Brook University
Collaborators
DrinkHRW
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1. Study Identification

Unique Protocol Identification Number
NCT05278260
Brief Title
Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients
Official Title
Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
DrinkHRW

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
head and neck cancer, radiation therapy, supportive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Active
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrogen tablets
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Number of participants who develop grade 3 oropharyngeal mucositis
Time Frame
3 months after completing radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Moran, NP
Phone
(631) 444-2210
Email
Clare.Moran@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Vacchi-Suzzi, PhD
Phone
631-216-2993
Email
caterina.vacchi-suzzi@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartik Mani, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Vacchi-Suzzi, PhD
Phone
631-216-2993
Email
caterina.vacchi-suzzi@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Clare Moran, DNP
Phone
631-459-0049
Email
Clare.Moran@stonybrookmedicine.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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