New drug aims to spare cancer patients from debilitating mouth sores

NCT ID NCT05966194

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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