Health TrialsbyHealthPanel

Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

ConditionsMucositisNephrotoxicityOtotoxicity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatrix Biomed, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);

Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;

If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;

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;

Disqualifiers

Prior radiotherapy of the head and neck;

Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment;

Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;

Be taking mugard;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tempol

    Drug

    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.

  • Placebo Solution

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Active 1000 mg Tempol SolutionActive comparator 1 intervention
Group B: Placebo SolutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mucositis

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.

Time frame
10 weeks

Secondary outcomes

1

Mucositis

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.

Time frame
10 weeks
2

Nephrotoxicity

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

Time frame
10 weeks
3

Nephrotoxicity

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

Time frame
10 weeks
4

Mucositis

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.

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matrix Biomed, Inc.

Lead sponsor

Source ClinicalTrials.gov
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