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

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 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 Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Receive usual symptom management
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood, serum, and/or plasma samples
• Cisplatin — DRUG
  Given cisplatin
• Computed Tomography — PROCEDURE
  Undergo CT
• Image Guided Radiation Therapy — RADIATION
  Undergo image-guided radiation therapy
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo intensity-modulated radiation therapy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• MnSOD Mimetic BMX-001 — DRUG
  Given SC
• Placebo Administration — DRUG
  Given SC
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Jun 23, 2025

Status verified

Apr 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

98 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Placebo Comparator: Arm 1 (placebo)
  Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive placebo SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.
• Experimental: Arm 2 (BMX-001)
  Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Primary Outcome Measure

Incidence of severe oral mucositis (SOM) [ Time Frame: From start of radiation through 4 weeks after completion of study treatment ]

Locations (149)

Find similar trials in Gilbert, AZ

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