At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with medically diagnosed squamous cell cancer of head and neck (SCCHN)
- ✓Scheduled to receive radiotherapy or proton therapy with curative intent
- ✓Receiving cisplatin for chemotherapy
- ✓ECOG performance status score ≤2
- ✕Prior radiotherapy of head and neck
- ✕Clinically significant acute viral, bacterial, or fungal infection requiring specific therapy (must complete anti-infectious therapy within 14 days)
- ✕Use of non-approved therapies for oral mucositis including β-carotene, tocopherol, laser irradiation, systemic TGF-β, or systemic KGF during or within 14 days of starting treatment
- ✕Use of mugard
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03480971Phase 2RecruitingUpdate OverdueUpdated 19mo ago · Completion was 12mo agoA 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
In Brief
A Phase 2 clinical trial evaluating Tempol and Placebo Solution for Mucositis and 2 related conditions. Currently recruiting, targeting 120 participants across 9 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
The placebo contains the same excipients as the active product plus FD\&C Yellow #6 for color matching.