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

• Status: RECRUITING
• Trial end date: 2027-01-01

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.

• Phase: PHASE2

Details

• Lead Sponsor: NRG Oncology
• Treatments: 1,2-diaminocyclohexaneplatinum II citrate; Cisplatin; Magnetic Resonance Spectroscopy; Mn(III) meso-tetrakis(N-n-butoxyethylpyridinium-2-yl)porphyrin; Platinum; Practice Guidelines as Topic; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Specimen Handling; Standard of Care