Back to resultsHydrogen-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
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
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
NCT ID
NCT05278260
First Posted
March 3, 2022
Last Updated
October 13, 2023
Sponsor
Stony Brook University
Collaborators
DrinkHRW
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
We'll reach out to this number within 24 hrs