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
Public ClinicalTrials.gov record NCT06532279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06532279
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 98 participants
Conditions and interventions
Conditions
- Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Head and Neck Squamous Cell Carcinoma
- Hypopharyngeal Squamous Cell Carcinoma
- Laryngeal Squamous Cell Carcinoma
- Nasopharyngeal Squamous Cell Carcinoma
- Oral Cavity Squamous Cell Carcinoma
- Oropharyngeal Squamous Cell Carcinoma
- Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage 0 Hypopharyngeal Carcinoma AJCC v8
- Stage 0 Nasopharyngeal Carcinoma AJCC v8
- Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage I Hypopharyngeal Carcinoma AJCC v8
- Stage I Laryngeal Cancer AJCC v8
- Stage I Lip and Oral Cavity Cancer AJCC v8
- Stage I Nasopharyngeal Carcinoma AJCC v8
- Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage II Hypopharyngeal Carcinoma AJCC v8
- Stage II Laryngeal Cancer AJCC v8
- Stage II Lip and Oral Cavity Cancer AJCC v8
- Stage II Nasopharyngeal Carcinoma AJCC v8
- Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Nasopharyngeal Carcinoma AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Nasopharyngeal Carcinoma AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stomatitis
Interventions
- Best Practice Other
- Biospecimen Collection Procedure
- Cisplatin Drug
- Computed Tomography Procedure
- Image Guided Radiation Therapy Radiation
- Intensity-Modulated Radiation Therapy Radiation
- Magnetic Resonance Imaging Procedure
- MnSOD Mimetic BMX-001 Drug
- Placebo Administration Drug
- Questionnaire Administration Other
Other · Procedure · Drug + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2025 (Actual)
- Primary completion
- Jan 1, 2027 (Estimated)
- Completion
- Jan 1, 2032 (Estimated)
- Last update posted
- Aug 17, 2026
2025 – 2032
United States locations
- U.S. sites
- 153
- U.S. states
- 30
- U.S. cities
- 129
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Center for Cancer Care - Gilbert | Gilbert | Arizona | 85297 | Recruiting |
| Arizona Center for Cancer Care-Peoria | Peoria | Arizona | 85381 | Recruiting |
| Arizona Center for Cancer Care - Phoenix | Phoenix | Arizona | 85027 | Recruiting |
| Arizona Center for Cancer Care - Scottsdale | Scottsdale | Arizona | 85258 | Recruiting |
| Arizona Center for Cancer Care-Surprise | Surprise | Arizona | 85374 | Recruiting |
| Arizona Center for Cancer Care | Tempe | Arizona | 85284 | Recruiting |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | 72401 | Recruiting |
| Keck Medicine of USC Buena Park | Buena Park | California | 90621 | Suspended |
| UC San Diego Health System - Encinitas | Encinitas | California | 92024 | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | Recruiting |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | Suspended |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Suspended |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | 92663 | Suspended |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | Recruiting |
| Shaw Cancer Center | Edwards | Colorado | 81632 | Recruiting |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | Recruiting |
| Sarasota Memorial Hospital-Venice | N. Venice | Florida | 34275 | Recruiting |
| Moffitt Cancer Center at SouthShore | Ruskin | Florida | 33570 | Recruiting |
| Florida Cancer Specialists - Sarasota | Sarasota | Florida | 34232 | Recruiting |
| Florida Cancer Specialists - Sarasota Downtown | Sarasota | Florida | 34239 | Recruiting |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | Recruiting |
| Sarasota Memorial Health Care Center at University Parkway | Sarasota | Florida | 34243 | Recruiting |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | Recruiting |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Florida Cancer Specialists - Venice Pinebrook | Venice | Florida | 34275 | Recruiting |
| Moffitt Cancer Center at Wesley Chapel | Wesley Chapel | Florida | 33544 | Recruiting |
| OSF Saint Joseph Medical Center | Bloomington | Illinois | 61701 | Recruiting |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | Recruiting |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Carle at The Riverfront | Danville | Illinois | 61832 | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | Recruiting |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | Recruiting |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | Recruiting |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | Recruiting |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | Recruiting |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | Recruiting |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | Recruiting |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | Recruiting |
| Northwestern Medicine Oak Brook | Oak Brook | Illinois | 60523 | Recruiting |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | Recruiting |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | Recruiting |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | Recruiting |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | Recruiting |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | Recruiting |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | Recruiting |
| Carle Cancer Center | Urbana | Illinois | 61801 | Recruiting |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | Recruiting |
| Illinois CancerCare - Washington | Washington | Illinois | 61571 | Recruiting |
| Baptist Health Floyd | New Albany | Indiana | 47150 | Recruiting |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | Recruiting |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | Recruiting |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | Recruiting |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | Recruiting |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | Recruiting |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | Recruiting |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | Recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| Salina Regional Health Center | Salina | Kansas | 67401 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| Baptist Health Hardin | Elizabethtown | Kentucky | 42701 | Recruiting |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02118 | Recruiting |
| McLaren Cancer Institute-Bay City | Bay City | Michigan | 48706 | Recruiting |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | Recruiting |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | Recruiting |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | Recruiting |
| Karmanos Cancer Institute at McLaren Greater Lansing | Lansing | Michigan | 48910 | Recruiting |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | Recruiting |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | Recruiting |
| McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | 48858 | Recruiting |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | Recruiting |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | Recruiting |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle | Columbus | Mississippi | 39705 | Recruiting |
| Baptist Cancer Center-Grenada | Grenada | Mississippi | 38901 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Union County | New Albany | Mississippi | 38652 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | Recruiting |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | Recruiting |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | Recruiting |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | Recruiting |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | Recruiting |
| Atrium Health Stanly/LCI-Albemarle | Albemarle | North Carolina | 28002 | Recruiting |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | Recruiting |
| Atrium Health Pineville/LCI-Pineville | Charlotte | North Carolina | 28210 | Recruiting |
| Atrium Health University City/LCI-University | Charlotte | North Carolina | 28262 | Recruiting |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| CaroMont Regional Medical Center | Gastonia | North Carolina | 28054 | Recruiting |
| Levine Cancer Institute-Gaston | Gastonia | North Carolina | 28054 | Recruiting |
| Hayworth Cancer Center | High Point | North Carolina | 27262 | Recruiting |
| Atrium Health Union/LCI-Union | Monroe | North Carolina | 28112 | Recruiting |
| Atrium Health Cleveland/LCI-Cleveland | Shelby | North Carolina | 28150 | Recruiting |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Recruiting |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | Recruiting |
| Aultman Health Foundation | Canton | Ohio | 44710 | Recruiting |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | 45069 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Chambersburg Hospital | Chambersburg | Pennsylvania | 17201 | Recruiting |
| Ephrata Cancer Center | Ephrata | Pennsylvania | 17522 | Recruiting |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | Recruiting |
| UPMC Cancer Center at UPMC Horizon | Farrell | Pennsylvania | 16121 | Recruiting |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | Recruiting |
| UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania | 15601 | Recruiting |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | 17109 | Recruiting |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | Recruiting |
| Sechler Family Cancer Center | Lebanon | Pennsylvania | 17042 | Recruiting |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion | Mechanicsburg | Pennsylvania | 17050 | Recruiting |
| UPMC Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Hillman Cancer Center - New Castle | New Castle | Pennsylvania | 16105 | Recruiting |
| UPMC-Saint Margaret | Pittsburgh | Pennsylvania | 15215 | Recruiting |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC-Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | Recruiting |
| UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania | 15243 | Recruiting |
| WellSpan Health-York Cancer Center | York | Pennsylvania | 17403 | Recruiting |
| Lancaster Radiation Therapy Center | Lancaster | South Carolina | 29720 | Recruiting |
| Rock Hill Radiation Therapy Center | Rock Hill | South Carolina | 29730 | Recruiting |
| Levine Cancer Institute-Rock Hill | Rock Hill | South Carolina | 29732 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Collierville | Collierville | Tennessee | 38017 | Recruiting |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | Recruiting |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | Recruiting |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | Recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | 54409 | Recruiting |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | 54806 | Recruiting |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | Recruiting |
| ProHealth D N Greenwald Center | Mukwonago | Wisconsin | 53149 | Active, not recruiting |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | Recruiting |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | Active, not recruiting |
| Aspirus Cancer Care - James Beck Cancer Center | Rhinelander | Wisconsin | 54501 | Recruiting |
| Aspirus Cancer Care - Stevens Point | Stevens Point | Wisconsin | 54481 | Recruiting |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | Active, not recruiting |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | Recruiting |
| Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | 54494 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06532279, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06532279 live on ClinicalTrials.gov.