RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-02
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05966194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.
  2. 2. Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of \> 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
  3. 3. ECOG performance status ≤ 2.
  4. 4. Participants must have adequate organ and marrow function as defined below:
  5. 5. Adequate renal and liver function as indicated by:
  6. 6. Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.
  7. 7. Age 18 years or older
  8. 8. Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.
  9. 9. Ability and willingness to understand and sign a written informed consent document.
  10. 10. Women of childbearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  11. * Has not undergone a hysterectomy or bilateral oophorectomy; or
  12. * Has not been postmenopausal for at least 12 consecutive months
  13. 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.
  1. 1. Prior radiotherapy to the head and neck region.
  2. 2. Prior induction chemotherapy.
  3. 3. Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
  4. 4. Patients with simultaneous primaries
  5. 5. Stage IV, M1 (distant metastasis)
  6. 6. Prior or current use of approved or investigational anticancer agent other than those provided in this study.
  7. 7. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal (solid) diet
  8. 8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason or prophylactic insertion of gastrostomy tube with dependency on tube feeding at baseline.
  9. 9. Malignant tumors other than squamous cell carcinoma of the head and neck within last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator.
  10. 10. Active infectious disease excluding oral candidiasis.
  11. 11. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at baseline.
  12. 12. Untreated active oral or dental infection
  13. 13. Known history of human immunodeficiency virus or active hepatitis B or C.
  14. 14. Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (e.g, immunosuppression, uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)
  15. 15. Use of the following within 48 hours of enrollment and duration of Oral Mucositis follow up: vitamin B12 (cobalamin) or synthetic vitamin B12, cyanocobalamin, or the vitamin B12 precursor, cobinamide, or any supplement or multivitamin with vitamin B12 or vitamin E in it since both vitamin B12 and vitamin E interact negatively with RRx-001.
  16. 16. Use of prebiotics and probiotics
  17. 17. Pregnant or nursing.
  18. 18. Known allergies or intolerance to cisplatin or other platinum-containing compounds.
  19. 19. Sjogren syndrome

Contacts and Locations

Study Contact

Scott Caroen
CONTACT
8589476635
scaroen@epicentrx.com
Jeannie Williams
CONTACT
8589476635
jwilliams@epicentrx.com

Principal Investigator

Meaghan Stirn
STUDY_DIRECTOR
EpicentRx, Inc.

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
The University of Arizona Cancer Center
Tucson, Arizona, 85719
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
United States
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
United States
Sandra and Malcolm Berman Cancer Institute
Baltimore, Maryland, 21204
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27834
United States
The Ohio State University James Cancer Hospital & Solove Research Institute
Columbus, Ohio, 43210
United States
Ballad Health
Johnson City, Tennessee, 37604
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: EpicentRx, Inc.

  • Meaghan Stirn, STUDY_DIRECTOR, EpicentRx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • Head and Neck Cancer
  • Neck cancer
  • Oral cancer
  • Mucositis
  • Squamous cell carcinoma (SCC)
  • HPV
  • Oropharynx
  • Oral cavity
  • IMRT

Additional Relevant MeSH Terms

  • Oral Mucositis