Study on RRx-001 for Reducing Mouth Sores in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

Sponsor: EpicentRx, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05966194

Provider View

This clinical trial is testing whether adding the drug RRx-001 to standard chemotherapy and radiation treatment can reduce severe mouth sores in patients with head and neck cancer. Participants will receive either RRx-001 or a placebo before starting their standard treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if RRx-001, when added to the usual treatment of cisplatin and radiation, can help reduce severe mouth sores in patients with head and neck cancer. All participants will undergo 7 weeks of standard radiation therapy along with the chemotherapy drug cisplatin. Before starting this treatment, they will receive either RRx-001 or a placebo.

Description

The current standard treatment for head and neck cancer involves using a chemotherapy drug called cisplatin, which is given through an IV, and radiation therapy that targets the tumor. A common side effect of this treatment is oral mucositis, which causes painful sores in the mouth. These sores can lead to severe pain, difficulty eating and drinking, increased risk of infection, and may even delay or stop treatment. There is currently only one approved treatment to prevent or manage these sores. This study is exploring whether adding RRx-001 to the treatment can help reduce the occurrence of these painful mouth sores.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oral cavity or oropharynx. Patients with cancers presumed to originate from the oropharynx may be included if they meet specific radiation criteria. HPV status must be determined for all patients.
  • Planned to receive standard radiation therapy with daily doses of 2.0 to 2.2 Gy, totaling 60-72 Gy, along with chemotherapy. Radiation must cover at least two oral sites, each receiving more than 55 Gy. Patients who have had surgery or may have surgery in the future are eligible.
  • ECOG performance status of 2 or less.
  • Adequate organ and bone marrow function, including:
    • Neutrophil count of at least 1,500/mm³
    • Platelet count of at least 75,000/mm³
    • Hemoglobin level of at least 9.0 g/dL
  • Adequate kidney and liver function as indicated by specific blood tests.
  • HPV status in the tumor must be documented for oropharyngeal cancers.
  • Age 18 years or older.
  • Consent to allow access to previous medical and cancer history.
  • Ability to understand and sign informed consent.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for 90 days after.
  • Adequate visual access to examine specific oral cavity sites.

Exclusion Criteria

  • Previous radiation therapy to the head and neck.
  • Previous induction chemotherapy.
  • Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
  • Multiple primary cancers.
  • Stage IV cancer with distant metastasis.
  • Previous or current use of other anticancer agents not provided in this study.
  • Severe difficulty swallowing or inability to eat solid food.
  • Need for tube feeding or parenteral nutrition at the start of the study.
  • Other malignant tumors within the last 5 years, unless low risk of recurrence.
  • Active infectious disease, except oral candidiasis.
  • Presence of oral mucositis or other mouth ulcers at the start of the study.
  • Untreated active oral or dental infection.
  • Known history of HIV or active hepatitis B or C.
  • Significant medical conditions that increase the risk of participating, such as uncontrolled diabetes or heart failure.
  • Pregnant or nursing women.
  • Known allergies to cisplatin or similar drugs.
  • Sjogren syndrome.

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