Clinical Trials Logo
  1. Home
  2. Mucositis Oral
  3. NCT05278260
  4. Details
NCT05278260 Clinical Trial

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

Mucositis Oral Clinical Trial

Official title:
Hydrogen Rich Water to Mitigate Acute Mucositis During Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05278260
Other study ID # SBU-HYDROGEN-HN-RT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date September 2024

Study information
Verified date October 2023
Source Stony Brook University
Contact Clare Moran, NP
Phone (631) 444-2210
Email Clare.Moran@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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
• 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

Locations
Country Name City State
United States Stony Brook Cancer Center Stony Brook New York

Sponsors (2)
Lead Sponsor Collaborator
Stony Brook University DrinkHRW

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who develop grade 3 oropharyngeal mucositis 3 months after completing radiation therapy
See also
  Status Clinical Trial Phase
Withdrawn NCT05331131 - Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial Phase 2
Not yet recruiting NCT06031012 - Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis Phase 3
Not yet recruiting NCT04080622 - Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation. Phase 3
Recruiting NCT06217224 - Evaluation of Prophylactic Photobiomodulation Therapy in Patients With Osteosarcoma N/A
Completed NCT03416582 - Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration N/A
Completed NCT03577535 - Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients. Phase 2
Recruiting NCT04596410 - Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children N/A
Recruiting NCT05308732 - Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy Phase 1
Completed NCT00293462 - GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 3
Recruiting NCT05926297 - Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel N/A
Recruiting NCT04671862 - Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis N/A
Recruiting NCT05926557 - Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel N/A
Completed NCT04187222 - Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis Phase 3
Completed NCT05307445 - Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy N/A
Completed NCT05214495 - Omega-3 Hydrogel and Prevention of Oral Mucositis Phase 2/Phase 3
Not yet recruiting NCT04303312 - Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis Phase 3
Recruiting NCT03983369 - Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults Phase 3
Completed NCT06049511 - Oral Self Care Protocol and Oral Mucositis N/A
Not yet recruiting NCT05224882 - Chemotherapy Oral Manifestations and Dental Awareness Among Parents
Active, not recruiting NCT03461354 - MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer N/A