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Cox-2 Inhibition in Radiation-induced Oral Mucositis

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ClinicalTrials.gov Identifier: NCT00698204
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: celecoxib Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
Study Start Date : July 2003
Primary Completion Date : September 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: I- Celecoxib Drug: celecoxib
Subject was asked to take celecoxib each day that radiation therapy was given.
Other Name: Celebrex
Placebo Comparator: II Drug: placebo
Subject was asked to take placebo each day that radiation therapy was given.


Outcome Measures

Primary Outcome Measures :
  1. Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy [ Time Frame: 5 weeks from start of radiation therapy (5000 cGy) ]

    Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9.

    The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups.



Secondary Outcome Measures :
  1. Evaluation of Pain Severity at 5000 cGy Radiation [ Time Frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy) ]
    Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patients who will be receiving at least 5000 centigray (cGy) radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
  • Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
  • Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

  • Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
  • Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or Non-steroidal anti-inflammatory drugs (NSAIDs).
  • Patients who have demonstrated allergic-type reactions to sulfonamides.
  • Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
  • Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
  • Patients with severe hepatic impairment.
  • Patients with advanced renal disease.
  • Patients with a significant bleeding disorder.
  • Patients under the age of 18 or over the age of 75.
  • Women who are pregnant or nursing.
  • Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
  • Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
  • Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698204


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1605
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
UConn Health
National Institute of Dental and Craniofacial Research (NIDCR)
Pfizer
Investigators
Principal Investigator: Rajesh V Lalla, DDS, Ph.D, CCRP UConn Health
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rajesh Lalla, Associate Professor, Oral Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00698204     History of Changes
Other Study ID Numbers: IRB 03 -157- 2
GCRC 487 ( Other Identifier: UCHC Clinical Research Center )
COXAON-0509-150 ( Other Identifier: Pfizer, Inc. )
K23DE016946-05 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2008    Key Record Dates
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: May 2014

Keywords provided by Rajesh Lalla, University of Connecticut Health Center:
Mucositis
Head and Neck Cancer
Head and Neck Neoplasms
Stomatitis

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents