Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
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
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
Treatments tested in this trial
- Tempol
- Placebo Solution
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov