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NCT06532279 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by NRG Oncology.

Recruiting
Registry status
Phase 2
Development phase
98
Enrollment target
20
Study locations

NCT06532279: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, sponsored by NRG Oncology.

NCT06532279 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 98 participants, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06532279, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by NRG Oncology.

RECRUITING
Registry status
Phase 2
Development phase
98 participants
Enrollment target
20
Study locations

Study 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

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

Conditions Studied

Head and Neck Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Oral Cavity Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Nasopharyngeal Squamous Cell Carcinoma Stage 0 Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • OTHER Best Practice
  • RADIATION Image Guided Radiation Therapy

Study Locations (20)

Arizona

  • Arizona Center for Cancer Care - Gilbert - Gilbert
  • Arizona Center for Cancer Care-Peoria - Peoria
  • Arizona Center for Cancer Care - Phoenix - Phoenix
  • Arizona Center for Cancer Care - Scottsdale - Scottsdale
  • Arizona Center for Cancer Care-Surprise - Surprise
  • Arizona Center for Cancer Care - Tempe

Florida

  • Sarasota Memorial Hospital-Venice - N. Venice
  • Moffitt Cancer Center at SouthShore - Ruskin
  • Florida Cancer Specialists - Sarasota - Sarasota
  • Florida Cancer Specialists - Sarasota Downtown - Sarasota
  • Sarasota Memorial Hospital - Sarasota
  • Sarasota Memorial Health Care Center at University Parkway - Sarasota

California

  • Keck Medicine of USC Buena Park - Buena Park
  • UC San Diego Moores Cancer Center - La Jolla
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach

Arkansas

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro

Colorado

  • Shaw Cancer Center - Edwards

District of Columbia

  • George Washington University Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2024-12-16
Est. Completion 2027-01-01
Phase Phase 2
NRG Oncology

64 total trials

What NCT06532279 shows while recruiting

NCT06532279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (16% lower).

The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06532279 names 20 study sites across 6 states, led by Arizona, Florida, California.

Frequently Asked Questions

What is clinical trial NCT06532279 about?

NCT06532279 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06532279?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2024-12-16. Estimated completion is 2027-01-01.

What conditions does trial NCT06532279 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.

What interventions are being tested in trial NCT06532279?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Best Practice (OTHER), Image Guided Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT06532279?

This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06532279 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06532279's enrollment target sits among peer trials

98 42nd of 124 higher than 83 of 124 other Head and Neck Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06532279

Source: ClinicalTrials.gov NCT06532279, the US trial registry maintained by the National Library of Medicine. NCT06532279 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.