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RRx-001 for Reducing Oral Mucositis in Head and Neck Cancer

This study is testing if RRx-001 can reduce severe oral mucositis (mouth sores) in people with head and neck cancer. Oral mucositis is a common and painful side effect of standard treatments like cisplatin (a chemotherapy drug) and radiation. All participants will receive 7 weeks of standard treatment with cisplatin and Intensity Modulated Radiation Therapy (IMRT). Some will also receive RRx-001, while others will receive a placebo (an inactive substance) before their standard treatment. The main goal is to see how many people develop severe oral mucositis during and after radiation therapy, up to 18 months. You may be able to join if you are 18 or older and have squamous cell carcinoma (a type of cancer) of the oral cavity or oropharynx. The current status of this study is unclear.

Study design
This interventional study plans to enroll 216 participants. It compares RRx-001 to a placebo, given in addition to standard chemotherapy and radiation.
What's involved
You would receive 7 weeks of standard radiation therapy and cisplatin. You would also receive RRx-001 or a placebo before your standard treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will track the incidence of severe oral mucositis for up to 18 months after Intensity-modulated radiation therapy (IMRT).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05966194

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
EpicentRx, Inc.
~216 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:RRx-001Intensity Modulated Radiation Therapy (IMRT)Cisplatin for injection 100 mg/m2

At a glance

Recruiting sites
0 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
Measured over Estimated up to 18 Months

Conditions

Oral Mucositis

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Head and Neck Squamous Cell CarcinomaHPV

Where it's being run

14 sites across 13 states
Arizona2
Florida1
Illinois1
Indiana1
Louisiana1
Maryland1
Michigan1
Nevada1

Study leadership

  • Meaghan Stirn · STUDY_DIRECTOR · EpicentRx, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been postmenopausal for at least 12 consecutive months 11. Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.

What this trial measures

  • Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)Estimated up to 18 Months

    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