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
NCT06532279 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2026-05-04
Summary
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.
Conditions
- 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
- 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 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
- 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
- OTHER
-
Best Practice
Receive usual symptom management
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood, serum, and/or plasma samples
- DRUG
-
Given cisplatin
- PROCEDURE
-
Computed Tomography
Undergo CT
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
David M Brizel · NRG Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-23
- Primary Completion
- 2027-01-01
- Completion
- 2027-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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