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
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
NRG Oncology
98 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Receive usual symptom management
Undergo collection of blood, serum, and/or plasma samples
Given cisplatin
Undergo CT
Undergo image-guided radiation therapy
Undergo intensity-modulated radiation therapy
Undergo MRI
Given SC
Given SC
Ancillary studies
Locations(149)
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NCT06532279