New drug aims to spare cancer patients from debilitating mouth sores

NCT ID NCT05966194

Ongoing Symptom relief Sponsor: EpicentRx, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether the drug RRx-001 can prevent severe oral mucositis (painful mouth sores) in 216 patients with head and neck cancer receiving standard chemoradiation. Patients are randomly assigned to receive RRx-001 or a placebo alongside their usual treatment. The main goal is to see if RRx-001 reduces the number of patients who develop severe mouth sores.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: RRx-001
What this could lead to: If it works, this could provide a way to prevent severe mouth sores during cancer treatment, improving quality of life for head and neck cancer patients.
What could go wrong: This is a mid-stage trial with 216 participants, so results are not yet proven. The drug may not reduce mouth sores more than placebo, and side effects from the drug itself are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms Mouth Neoplasms mucositis oral cavity squamous cell carcinoma oropharynx squamous cell carcinoma squamous cell carcinoma stomatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ORAL MUCOSITIS

Contacts and locations

Locations

Ballad Health

Johnson City, Tennessee, 37604, United States
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
East Carolina University School of Medicine

Greenville, North Carolina, 27834, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States
Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Sandra and Malcolm Berman Cancer Institute

Baltimore, Maryland, 21204, United States
The Ohio State University James Cancer Hospital & Solove Research Institute

Columbus, Ohio, 43210, United States
The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Virginia

Charlottesville, Virginia, 22908, United States
Willis Knighton Cancer Center

Shreveport, Louisiana, 71103, United States

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