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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• 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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

NRG Oncology

Last updated on ClinicalTrials.gov

August 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites