Patients will take 600 mg of Tempol a day for the duration of radiation treatment (6-8 weeks)

Patients will take placebo solution everyday for the duration of radiation treatment (6-8 weeks)

Mucositis

Nephrotoxicity

Ototoxicity

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.

Tempol

The placebo contains the same excipients as the active product plus FD&C Yellow #6 for color matching.

Placebo Solution

UCSD

The University of Kansas Cancer Center

University Maryland School of Medicine

Washington University

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

To determine the efficacy of Tempol in reducing the incidence severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.
The incidence will measure the number of patients who experience grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the number of patients who receive grade 3 or 4 mucositis over the course of the treatment is considered a positive change in incidence.

To determine the efficacy of Tempol in reducing the duration severe mucositis defined as grade 3 or 4 on the World Health Organization (WHO) scale.
This duration will be measured by total number of days number a patient experiences grade 3 or 4 mucositis according to the World Health Organization (WHO) scale. A reduction in the total number of days a patient receives grade 3 or 4 mucositis over the course of the treatment is considered a positive change in duration.

Reduction in Serum Creatinine levels in active arm versus placebo arm.

Reduction in Blood Urea Nitrogen levels in active arm versus placebo arm.

To determine the efficacy of Tempol in reducing the time to onset of grades 1-4 mucositis on the World Health Organization (WHO) scale.
This time to onset will measure the number of days after exposure to cisplatin before a patient experiences grade 1 through 4 mucositis according to the World Health Organization (WHO) scale. An increase in the total number of days before a patient receives grade 1 through 4 mucositis after cisplatin exposure is considered a positive change in time to onset.

Matrix Biomed, Inc.

University of Maryland, College Park

Anal Cancer

Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT.

5-FU will be delivered as 1000mg/m2/day as 96 hour continuous infusion beginning on day 1 and 29.

5-Fluorouracil

MMC will be delivered at a dose of 10mg/m2 on days 1 and 29

Mitomycin-C

RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics.

Radiation Therapy

National Institutes of Health Clinical Center, 9000 Rockville Pike

Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer

A Pilot Trial Assessing the Feasibility of Delivering Topical MTS-01 to Reduce Dermatitis in Patients Receiving Intensity Modulated Radiation With Concurrent 5-Fluorouracil and Mitomycin-C for Stage I-III Carcinoma of the Anal Canal

National Cancer Institute (NCI)

Prostate Cancer

Uroxatrol (drug)

New York Prostate Institute

Prophylactic Vs. Therapeutic Use of Uroxatrol in Men Undergoing Brachytherapy

Randomized, Open-Labeled Study of Prophylactic Vs. Therapeutic Use of Uroxatrol to Determine Improvements in Urinary Morbidity Following Men Undergoing Prostate Brachytherapy

piperidine/vähk

Treatment of Radiation and Cisplatin Induced Toxicities With Tempol

Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer

Prophylactic Vs. Therapeutic Use of Uroxatrol in Men Undergoing Brachytherapy

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