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Cox-2 Inhibition in Radiation-induced Oral Mucositis

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
placebo
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Connecticut Health Center
  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

I- Celecoxib

II

Arm Description

Outcomes

Primary Outcome Measures

Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 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

Evaluation of Pain Severity at 5000 cGy Radiation
Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable

Full Information

First Posted
June 12, 2008
Last Updated
May 7, 2014
Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00698204
Brief Title
Cox-2 Inhibition in Radiation-induced Oral Mucositis
Official Title
Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I- Celecoxib
Arm Type
Experimental
Arm Title
II
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Subject was asked to take celecoxib each day that radiation therapy was given.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subject was asked to take placebo each day that radiation therapy was given.
Primary Outcome Measure Information:
Title
Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy
Description
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.
Time Frame
5 weeks from start of radiation therapy (5000 cGy)
Secondary Outcome Measure Information:
Title
Evaluation of Pain Severity at 5000 cGy Radiation
Description
Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable
Time Frame
5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh V Lalla, DDS, Ph.D, CCRP
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1605
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25151488
Citation
Lalla RV, Choquette LE, Curley KF, Dowsett RJ, Feinn RS, Hegde UP, Pilbeam CC, Salner AL, Sonis ST, Peterson DE. Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis in patients receiving radiation therapy for head and neck cancer. Oral Oncol. 2014 Nov;50(11):1098-103. doi: 10.1016/j.oraloncology.2014.08.001. Epub 2014 Aug 21.
Results Reference
derived

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Cox-2 Inhibition in Radiation-induced Oral Mucositis

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