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NCT05966194 · ClinicalTrials.gov registry record · Phase 2
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
A Phase 2 study of Oral Mucositis, sponsored by EpicentRx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
- 14
- Study locations
NCT05966194: Recruiting Phase 2 study of Oral Mucositis, sponsored by EpicentRx.
NCT05966194 is a Phase 2 study of Oral Mucositis that is actively recruiting participants, run by EpicentRx. The registered enrollment target is 216 participants, above the 86-participant average among 10 other Oral Mucositis trials with a reported enrollment target (151% higher). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05966194, a Phase 2 study of Oral Mucositis, is actively recruiting participants, sponsored by EpicentRx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
The incidence of SOM defined as the proportion of patients with any WHO Grade \>= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT
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
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 2 |
What NCT05966194 shows while recruiting
NCT05966194 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 10 other Oral Mucositis trials with a reported enrollment target (151% higher).
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.
NCT05966194 lists 14 locations in 13 states (Arizona, Florida, Illinois).
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.
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).
Who is sponsoring clinical trial NCT05966194?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Oral Mucositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05966194's enrollment target sits among peer trials
216 2nd of 10 the highest of 10 other Oral Mucositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Mucositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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