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Cox-2 Inhibition in Radiation-induced Oral Mucositis

NCT00698204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-06-05

Study results available
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Summary

Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.

Conditions

  • Oral Mucositis

Interventions

DRUG

celecoxib

Subject was asked to take celecoxib each day that radiation therapy was given.

DRUG

placebo

Subject was asked to take placebo each day that radiation therapy was given.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • UConn Health

    lead OTHER

Principal Investigators

  • Rajesh V Lalla, DDS, Ph.D, CCRP · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2012-09-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698204 on ClinicalTrials.gov