RecruitingPhase 2NCT03480971

Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

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


Sponsor

Matrix Biomed, Inc.

Enrollment

120 participants

Start Date

May 13, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a topical antioxidant drug called Tempol to see if it can reduce painful side effects — particularly mouth sores (mucositis) and dry mouth — caused by radiation and cisplatin chemotherapy in patients being treated for head and neck cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the head and neck - You are scheduled to receive radiation (or proton therapy) with curative intent and are also receiving cisplatin chemotherapy - Your overall health and organ function (blood counts, liver, kidneys) are within acceptable ranges - Your life expectancy is at least 6 months - You are in good enough health to tolerate treatment (ECOG ≤2) **You may NOT be eligible if...** - You have had prior radiation to the head and neck - You have an active serious infection that requires treatment - You are using specific other mouth/mucositis medications (such as mugard, allopurinol rinses, or prostaglandins) - You have HIV, hepatitis B, or hepatitis C - You have insulin-dependent diabetes - You are pregnant or breastfeeding - You weigh less than 77 lbs. (35 kg) - You have a known allergy to platinum-based drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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)

UCSD

La Jolla, California, United States

Mercy Medical Center

Merced, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Central Coast Medical Oncology

Santa Maria, California, United States

Mission Hope Health Center

Santa Maria, California, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03480971


Related Trials