Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

{ "Tempol for Reducing Side Effects of Head and Neck Cancer Treatment", "This study is testing whether an oral solution called Tempol can help prevent or reduce common side effects from radiation and cisplatin chemotherapy for head and neck cancer. These side effects include mucositis (mouth sores), nephrotoxicity (kidney damage), and ototoxicity (hearing damage). You may be able to join if you are 18 or older, have squamous cell cancer of the head and neck, and are scheduled to receive radiation therapy. The study aims to enroll 120 participants and will monitor these side effects over 10 weeks to see if Tempol is effective. A placebo solution, which looks and tastes similar to Tempol but contains no active medicine, will also be used for comparison.", "design": "This interventional study plans to enroll 120 participants. It compares Tempol oral solution to a placebo solution.", "commitments": "Participants will be monitored and assessed for mucositis, nephrotoxicity, and ototoxicity over a 10-week period.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be monitored for 10 weeks, with mucositis measured at the end of this period.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT03480971

Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Recruiting
PHASE2Ages 18+InterventionalTreatment
Matrix Biomed, Inc.
~120 participants
Updated 2024-11-20 on ClinicalTrials.gov
What's tested:TempolPlacebo Solution

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mucositis
Measured over 10 weeks
Mucositis
Nephrotoxicity
Ototoxicity
9 sites across 4 states
California5
Washington2
New York1
North Carolina1
  • Benji Crane · STUDY_DIRECTOR · Matrix Biomed, Inc.

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  • Mucositis10 weeks

    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.