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RECRUITING Phase 2

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

NCT05966194 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • RADIATION Intensity Modulated Radiation Therapy (IMRT)
  • DRUG RRx-001
  • DRUG Cisplatin for injection 100 mg/m2

Study Locations (14)

Arizona

  • Banner MD Anderson Cancer Center — Gilbert
  • The University of Arizona Cancer Center — Tucson

Florida

  • Miami Cancer Institute — Miami

Illinois

  • Northwestern University Feinberg School of Medicine — Chicago

Indiana

  • Parkview Cancer Institute — Fort Wayne

Louisiana

  • Willis Knighton Cancer Center — Shreveport

Maryland

  • Sandra and Malcolm Berman Cancer Institute — Baltimore

Michigan

  • University of Michigan — Ann Arbor

Nevada

  • Renown Regional Medical Center — Reno

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2024-04-02
Est. Completion 2025-10-01
Phase Phase 2

Sponsor

EpicentRx

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05966194

The ClinicalTrials.gov registry entry for NCT05966194 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EpicentRx, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Oral Mucositis appearing as the primary indexed condition, and to 3 interventions — of which Intensity Modulated Radiation Therapy (IMRT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05966194 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Arizona, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05966194 about?

NCT05966194 is a clinical study titled "RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer". 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 th...

What is the current status of trial NCT05966194?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2024-04-02. Estimated completion is 2025-10-01.

What conditions does trial NCT05966194 study?

This clinical trial studies the following conditions: Oral Mucositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05966194?

The interventions under investigation include: Intensity Modulated Radiation Therapy (IMRT) (RADIATION), RRx-001 (DRUG), Cisplatin for injection 100 mg/m2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05966194?

This trial is sponsored by EpicentRx, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05966194 being conducted?

This trial has 14 study locations across Arizona, Florida, Illinois, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial