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NCT03480971 · ClinicalTrials.gov registry record · Phase 2
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A Phase 2 study of Mucositis and Ototoxicity, sponsored by Matrix Biomed.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 9
- Study locations
NCT03480971: Recruiting Phase 2 study of Mucositis and Ototoxicity, sponsored by Matrix Biomed.
NCT03480971 is a Phase 2 study of Mucositis and Ototoxicity that is actively recruiting participants, run by Matrix Biomed. The registered enrollment target is 120 participants, above the 31-participant average among 4 other Mucositis trials with a reported enrollment target (287% higher). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480971, a Phase 2 study of Mucositis and Ototoxicity, is actively recruiting participants, sponsored by Matrix Biomed.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Tempol
- DRUG Placebo Solution
Study Locations (9)
California
- UCSD - La Jolla
- Mercy Medical Center - Merced
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
- Central Coast Medical Oncology - Santa Maria
- Mission Hope Health Center - Santa Maria
Washington
- Seattle Cancer Care Alliance - Seattle
- University of Washington Medical Center - Seattle
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT03480971 shows while recruiting
NCT03480971 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 31-participant average among 4 other Mucositis trials with a reported enrollment target (287% higher).
The record links to 3 conditions, with Mucositis appearing as the primary indexed condition, and to 2 interventions - of which Tempol is the first listed.
NCT03480971 lists 9 locations in 4 states (California, Washington, New York).
Frequently Asked Questions
What is clinical trial NCT03480971 about?
NCT03480971 is a clinical study titled "Treatment of Radiation and Cisplatin Induced Toxicities with Tempol". 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.
What is the current status of trial NCT03480971?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-05-13. Estimated completion is 2025-12.
What conditions does trial NCT03480971 study?
This clinical trial studies the following conditions: Mucositis, Ototoxicity, Nephrotoxicity.
What interventions are being tested in trial NCT03480971?
The interventions under investigation include: Tempol (DRUG), Placebo Solution (DRUG).
Who is sponsoring clinical trial NCT03480971?
This trial is sponsored by Matrix Biomed, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03480971 being conducted?
This trial has 9 study locations across California, New York, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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