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

Incidence of severe oral mucositis (SOM)

Proportion of patients with reported SOM \>= grade 3 per World Health Organization criteria.

Duration of SOM

Defined from first determination of \>= grade 3 oral mucositis (OM) to the first instance of non-SOM (=\< grade 2), without subsequent instance of \>= grade 3 within the following 4 weeks.

Time to SOM

Defined from date of randomization to date of first determination of \>= grade 3 OM.

Incidence and duration of xerostomia and radiation dermatitis

The proportion of patients with any grade and grade ≥ 3 xerostomia and radiation dermatitis, separately. Duration is measured from the first determination of radiation dermatitis or xerostomia, separately, (grade ≥ 1 as measured by Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) to the first report of none (grade 0).

Incidence of toxicity

Adverse events (AEs) will be graded by the physician-reported CTCAE v5.0 and also measured using the Patient Reported Outcome-CTCAE. Counts of all AEs by grade will be provided by treatment arm.

Pain improvement

Pain improvement will be measured by opioid use collected in morphine equivalent doses.

Progression-free survival (PFS)

PFS will be calculated from the date of randomization until occurrence of local, regional (neck lymph nodes) or distant failure, or death. PFS rates will be estimated using the Kaplan-Meier method. Patients without an event will be censored at their last disease assessment.

Overall survival (OS)

OS will be calculated from the date of randomization to death and estimated using the Kaplan-Meier method. Patients alive without an event will be censored at their last known follow-up time.