Actively Recruiting
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Led by EpicentRx, Inc. · Updated on 2024-11-15
216
Participants Needed
14
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with squamous cell carcinoma of the oral cavity or oropharynx
- Planned to receive standard intensity-modulated radiation therapy (IMRT) with daily doses of 2.0 to 2.2 Gy totaling 60-72 Gy alongside chemotherapy
- Radiation treatment fields must include at least two oral sites each receiving more than 55 Gy
- ECOG performance status of 2 or less
- Adequate organ and bone marrow function (ANC ≥ 1,500/mm3, platelets ≥ 75,000/mm3, hemoglobin ≥ 9.0 g/dL)
- Adequate kidney and liver function within specified laboratory limits
- Documented HPV status for oropharyngeal cancers; optional for oral cavity tumors
- Age 18 years or older
- Consent to allow review of previous medical and cancer history including imaging
- Willing and able to provide informed consent
- Women of childbearing potential and men with partners of childbearing potential must use effective contraception during and for 90 days after treatment
- Visual access to examine lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate
You will not qualify if you...
- Prior radiation therapy to head and neck
- Previous induction chemotherapy
- Tumors in lips, salivary gland, nasopharynx, hypopharynx, or larynx
- Presence of multiple simultaneous primary cancers
- Stage IV with distant metastasis (M1)
- Prior or current use of other approved or investigational anticancer agents outside this study
- Severe difficulty swallowing or pain (grade 3 or 4) or inability to eat solid food
- Need for parenteral or tube feeding or dependence on feeding tube at baseline
- Other malignant tumors within past 5 years unless low risk of recurrence
- Active infections excluding oral candidiasis
- Existing oral mucositis or other mouth ulcers at baseline
- Untreated active oral or dental infection
- Known HIV infection or active hepatitis B or C
- Significant medical conditions increasing risk such as immunosuppression, uncontrolled diabetes, heart failure, recent heart attack, severe lung disease, or active uncontrolled infection
- Use of vitamin B12, vitamin E supplements, prebiotics or probiotics within 48 hours before enrollment and during follow-up
- Pregnant or nursing
- Allergy or intolerance to cisplatin or platinum compounds
- Sjogren syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
6
Willis Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
7
Sandra and Malcolm Berman Cancer Institute
Baltimore, Maryland, United States, 21204
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
10
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27834
Actively Recruiting
11
The Ohio State University James Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Ballad Health
Johnson City, Tennessee, United States, 37604
Actively Recruiting
13
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
14
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
S
Scott Caroen
CONTACT
J
Jeannie Williams
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here