NCT05966194

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: EpicentRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	RRx-001	RRx-001 for injection (4 mg or 8 mg)
RADIATION	Intensity Modulated Radiation Therapy (IMRT)	Intensity Modulated Radiation Therapy of up to 72 Gy
DRUG	Cisplatin for injection 100 mg/m2	Cisplatin for injection 100 mg/m2

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2023-07-28
• Last updated: 2024-11-15

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study