A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy
Matrix Biomed, Inc.
Summary
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.
Description
One hundred and twenty (120) participants with head and neck cancer are scheduled to undergo combined radio- and chemotherapy (n = 120). Nearly all (90% to 97%) participants receiving radiotherapy in the head and neck will develop some degree of mucositis. Of these participants treated with radiotherapy with or without chemotherapy, 34% to 43% will present severe mucositis. As a result, the participant's quality of life is affected, hospital admittance rates are higher, the use of total parenteral nutrition is increased and interruption of treatment is more frequent, all of which compromise t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN); 2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent; 3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant; 4. If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study; 5. Must be receiving cisplat…
Interventions
- DrugTempol
Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.
- DrugPlacebo Solution
The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.
Locations (9)
- UCSDLa Jolla, California
- Mercy Medical CenterMerced, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Central Coast Medical OncologySanta Maria, California
- Mission Hope Health CenterSanta Maria, California
- Montefiore Medical Center-Einstein CampusThe Bronx, New York