RecruitingPhase 2NCT05966194

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx


Sponsor

EpicentRx, Inc.

Enrollment

216 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called RRx-001 to reduce oral mucositis — painful sores in the mouth and throat — that commonly develops during radiation and chemotherapy treatment for head and neck cancer. **You may be eligible if...** - You have confirmed squamous cell carcinoma of the oral cavity or oropharynx (mouth or throat cancer) - You are planned to receive standard intensity-modulated radiation therapy (IMRT) with daily fraction doses of 2.0 Gy or higher - You may also be receiving concurrent chemotherapy - You are eligible for concurrent chemoradiation treatment **You may NOT be eligible if...** - Your cancer is at a stage or location that does not require radiation doses meeting study criteria - You have serious medical conditions that make participation unsafe - You have had prior radiation to the head or neck - You cannot swallow oral medications or receive intravenous infusions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRRx-001

RRx-001 for injection (4 mg or 8 mg)

RADIATIONIntensity Modulated Radiation Therapy (IMRT)

Intensity Modulated Radiation Therapy of up to 72 Gy

DRUGCisplatin for injection 100 mg/m2

Cisplatin for injection 100 mg/m2


Locations(14)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

Miami Cancer Institute

Miami, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Parkview Cancer Institute

Fort Wayne, Indiana, United States

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Sandra and Malcolm Berman Cancer Institute

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Renown Regional Medical Center

Reno, Nevada, United States

East Carolina University School of Medicine

Greenville, North Carolina, United States

The Ohio State University James Cancer Hospital & Solove Research Institute

Columbus, Ohio, United States

Ballad Health

Johnson City, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05966194


Related Trials