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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06532279
The ClinicalTrials.gov registry entry for NCT06532279 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (16% lower). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.