Clinical trialNCT06532279RecruitingPhase 2Interventional

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer

SponsorNRG OncologyEnrollment98Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell Carcinoma+35 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David M Brizel
NRG Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

153 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States
Steven E. Sckolnik
Recruiting
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Steven E. Sckolnik
Recruiting
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States
Steven E. Sckolnik
Recruiting
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States
Steven E. Sckolnik
Recruiting
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, United States
Steven E. Sckolnik
Recruiting
Arizona Center for Cancer Care
Tempe, Arizona, United States
Steven E. Sckolnik
Recruiting
Nea Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Shelby Lane
Recruiting
Keck Medicine of Usc Buena Park
Buena Park, California, United States
Suspended
Uc San Diego Health System - Encinitas
Encinitas, California, United States
Karen M. Yun
Recruiting
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Karen M. Yun
Recruiting
Los Angeles General Medical Center
Los Angeles, California, United States
Suspended
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Suspended
Usc Norris Oncology/hematology-Newport Beach
Newport Beach, California, United States
Suspended
Uc San Diego Medical Center - Hillcrest
San Diego, California, United States
Karen M. Yun
Recruiting
Shaw Cancer Center
Edwards, Colorado, United States
Patricia H. Hardenbergh
Recruiting
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Sharad Goyal
Recruiting
Sarasota Memorial Hospital-Venice
N. Venice, Florida, United States
Kunal Saigal
Recruiting
Moffitt Cancer Center at Southshore
Ruskin, Florida, United States
Niema B. Razavian
Recruiting
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
Kunal Saigal
Recruiting
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States
Kunal Saigal
Recruiting
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, United States
Kunal Saigal
Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, United States
Kunal Saigal
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Niema B. Razavian
Recruiting
Moffitt Cancer Center - Mckinley Campus
Tampa, Florida, United States
Niema B. Razavian
Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Niema B. Razavian
Recruiting
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States
Kunal Saigal
Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Niema B. Razavian
Recruiting
Illinois Cancercare-Bloomington
Bloomington, Illinois, United States
Bryan A. Faller
Recruiting
Osf Saint Joseph Medical Center
Bloomington, Illinois, United States
Bryan A. Faller
Recruiting
Illinois Cancercare-Canton
Canton, Illinois, United States
Bryan A. Faller
Recruiting
Northwestern University
Chicago, Illinois, United States
Laila A. Gharzai
Recruiting
Carle at the Riverfront
Danville, Illinois, United States
Sinisa Stanic
Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Laila A. Gharzai
Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, United States
Sinisa Stanic
Recruiting
Illinois Cancercare-Eureka
Eureka, Illinois, United States
Bryan A. Faller
Recruiting
Illinois Cancercare-Galesburg
Galesburg, Illinois, United States
Bryan A. Faller
Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Laila A. Gharzai
Recruiting
Illinois Cancercare-Kewanee Clinic
Kewanee, Illinois, United States
Bryan A. Faller
Recruiting
Illinois Cancercare-Macomb
Macomb, Illinois, United States
Bryan A. Faller
Recruiting
Carle Physician Group-Mattoon/charleston
Mattoon, Illinois, United States
Sinisa Stanic
Recruiting

113 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cisplatin →MnSOD Mimetic BMX-001Placebo Administration

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 23 Jun 2025
Primary completion: 1 Jan 2027
Completion: 1 Jan 2032
Last update posted: 17 Aug 2026
Registered enrollment: 98
Registry id: NCT06532279

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.