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
NCT Number: NCT06532279
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8|Stage 0 Hypopharyngeal Carcinoma AJCC v8|Stage 0 Nasopharyngeal Carcinoma AJCC v8|Stage 0 Oropharyngeal (p16-Negative) Carcinoma AJCC v8|Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck 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
Interventions: OTHER: Best Practice|PROCEDURE: Biospecimen Collection|DRUG: Cisplatin|PROCEDURE: Computed Tomography|RADIATION: Image Guided Radiation Therapy|RADIATION: Intensity-Modulated Radiation Therapy|PROCEDURE: Magnetic Resonance Imaging|DRUG: MnSOD Mimetic BMX-001|DRUG: Placebo Administration|OTHER: Questionnaire Administration
Sponsor: NRG Oncology
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-30
Completion Date: 2026-09-15

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.

Primary Outcome Measures: Incidence of severe oral mucositis (SOM), Will be defined as \>= grade 3 per World Health Organization criteria. The difference in proportions between the two treatment arms would be tested using a test of proportions z-test with a one-sided significance level of 5%., From start of radiation through 4 weeks after completion of study treatment
Secondary Outcome Measures: Duration of SOM, The mean duration will be compared between arms using a t-test., 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, Gray's test will be used to assess between treatment arm comparisons. Cause-specific Cox proportional hazards models will be used to evaluate the effect of stratification factors and other relevant covariates., From date of randomization to date of first determination of >= grade 3 OM, assessed up to 24 months after completion of chemoradiation|Incidence and duration of xerostomia and radiation dermatitis, The rate of any grade and grade ≥ 3 xerostomia and radiation dermatitis, separately, will be compared between arms using a chi-square test. The mean duration will be compared between arms using a t-test., From first determination to first report of no xerostomia or radiation dermatitis, assessed up to 24 months after completion of chemoradiation|Incidence of toxicity, Adverse events (AEs) will be graded by the physician-reported Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and also measured using the Patient Reported Outcome-CTCAE. Counts of all AEs by grade will be provided by treatment arm., Up to 24 months after completion of chemoradiation|Patient reported oral mucositis, Will be measured by the Oral Mucositis Weekly Questionnaire (OMWQ). Decline within patients using a minimally important difference of 7 will be compared between arms at each timepoint using a chi-square test, or Fisher's exact test in the case of small cell counts., Up to 24 months after completion of chemoradiation
Other Outcome Measures: Change in Pain, Change in Pain will be measured by opioid use collected in morphine equivalent doses. Longitudinal mixed effects models will be used to assess the changes between treatment arms in opioid use over the course of the study. In addition to treatment arm and a treatment by time interaction, stratification factors and other relevant covariates will be included in the model., Up to 24 months after completion of chemoradiation|Progression-free survival (PFS), PFS will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested using the log rank test. The Cox proportional hazard model will be performed with the type of neck irradiation and other baseline characteristics as fixed variables to assess the treatment effect while adjusting for stratification factors and patient-specific risk factors., From the date of randomization until occurrence of local, regional (neck lymph nodes) or distant failure, or death, assessed up to 24 months after completion of chemoradiation|Overall survival (OS), OS will be estimated using the Kaplan-Meier method, and differences between treatment arms will be tested using the log rank test. The Cox proportional hazard model will be performed with the type of neck irradiation and other baseline characteristics as fixed variables to assess the treatment effect while adjusting for stratification factors and patient-specific risk factors., From the date of randomization to death, assessed up to 24 months after completion of chemoradiation