Cox-2 Inhibition in Radiation-induced Oral Mucositis

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Rajesh Lalla, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00698204
First received: June 12, 2008
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Oral Mucositis
Drug: celecoxib
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy [ Time Frame: 5 weeks from start of radiation therapy (5000 cGy) ] [ Designated as safety issue: No ]

    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:
  • Evaluation of Pain Severity at 5000 cGy Radiation [ Time Frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy) ] [ Designated as safety issue: No ]
    Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable


Enrollment: 43
Study Start Date: July 2003
Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Connecticut Health Center
Pfizer
Investigators
Principal Investigator: Rajesh V Lalla, DDS, Ph.D, CCRP University of Connecticut Health Center
  More Information

No publications provided

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, COXAON-0509-150, K23DE016946-05
Study First Received: June 12, 2008
Results First Received: May 7, 2014
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014