Treatment of Radiation and Cisplatin Induced Toxicities with Tempol (NCT03480971) | Clinical Trial Compass
RecruitingPhase 2
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
United States120 participantsStarted 2019-05-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Be β₯18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
β. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
β. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
β. 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;
β. Must be receiving cisplatin for chemotherapy;
β. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
β. Must have a score 2 or less on the ECOG performance status;
β. Participant life expectancy β₯ 6 months; and
Exclusion criteria
β. Prior radiotherapy of the head and neck;
β. 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;
β. Be taking any non-approved therapy for oral mucositis, including Ξ²-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-Ξ² (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;
β. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
β. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
β. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
β. Have used an investigational drug within 28 days of the initiation of study treatment;