RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Public ClinicalTrials.gov record NCT05966194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05966194
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- RRx-001 Drug
- Intensity Modulated Radiation Therapy (IMRT) Radiation
- Cisplatin for injection 100 mg/m2 Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2024
- Primary completion
- Jun 30, 2027
- Completion
- Sep 30, 2027
- Last update posted
- Jun 25, 2026
2024 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| The University of Arizona Cancer Center | Tucson | Arizona | 85719 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Parkview Cancer Institute | Fort Wayne | Indiana | 46845 | — |
| Willis Knighton Cancer Center | Shreveport | Louisiana | 71103 | — |
| Sandra and Malcolm Berman Cancer Institute | Baltimore | Maryland | 21204 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| East Carolina University School of Medicine | Greenville | North Carolina | 27834 | — |
| The Ohio State University James Cancer Hospital & Solove Research Institute | Columbus | Ohio | 43210 | — |
| Ballad Health | Johnson City | Tennessee | 37604 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05966194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05966194 live on ClinicalTrials.gov.