NCT06532279 · NRG Oncology
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
What this study is about
This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing taken by mouth mucositis in patients who are receiving chemoradiation for head and neck cancer. taken by mouth mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing.
View original scientific description
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.
Interventions
OTHER
Best Practice
Receive usual symptom management
PROCEDURE
Biospecimen Collection
Undergo collection of blood, serum, and/or plasma samples
DRUG
Cisplatin
Given cisplatin
PROCEDURE
Computed Tomography
Undergo CT
RADIATION
Image Guided Radiation Therapy
Undergo image-guided radiation therapy
RADIATION
Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
MnSOD Mimetic BMX-001
Given SC
DRUG
Placebo Administration
Given SC
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Incidence of severe oral mucositis (SOM)
Time frame: From start of radiation through 4 weeks after completion of study treatment
Proportion of patients with reported SOM \>= grade 3 per World Health Organization criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must be planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy. Patients planned to receive concurrent cisplatin and radiation therapy in the adjuvant setting are not eligible.
- At least two subsites (buccal mucosa, lips, retromolar trigone, floor of mouth, oral tongue, tonsil, soft palate, or hard palate) must have at least 1cc or 1% of the subsite volume receiving \>= 50 Gy. In cases of uncertainty, the enrolling clinician can ensure coverage by inspecting the 50 Gy isodose line and using the table describing the anatomic boundaries of the individual subsites contained within the extended cavity contour. The two or more subsites receiving \>= 50 Gy must be documented by the enrolling physician and will be reviewed centrally to confirm eligibility.
- Pathologically confirmed (histologically or cytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
- P16 and/or human
Where
- Gilbert, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Surprise, Arizona
- Tempe, Arizona
- Jonesboro, Arkansas
- Buena Park, California
- Encinitas, California
- La Jolla, California
- Los Angeles, California
- Newport Beach, California
And 117 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations