Cox-2 Inhibition in Radiation-induced Oral Mucositis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I- Celecoxib

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

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

II

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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celecoxib

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No