Oral Mucositis
Conditions
Keywords
Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis
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.
Interventions
DRUGcelecoxib
Subject was asked to take celecoxib each day that radiation therapy was given.
DRUGplacebo
Subject was asked to take placebo each day that radiation therapy was given.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Pfizer
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Pain Severity at 5000 cGy Radiation | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment period University of Connecticut Health Center: December 2003 through December 2004 and from March 2006 through June 2011. Recruitment period Hartford Hospital: March 2010 thorough June 2011.
Pre-assignment details
Three participants enrolled in the study but were not randomized. Two did not meet blood test eligibility criteria for randomization (liver function test, renal function test failure) and one withdrew shortly after enrolling, prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| I- Celecoxib celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given. | 20 |
| II- Placebo placebo: Subject was randomized to take placebo each day that radiation therapy was given. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | I- Celecoxib | II- Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.15 years | 56.00 years | 54.58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 18 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 6 / 20 | 5 / 20 |
Outcome results
Primary
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.
Time frame: 5 weeks from start of radiation therapy (5000 cGy)
Population: Subjects participating in the study as they reached a cumulative dose of 5000 cGy were included. One subject in the celecoxib group withdrew prior to reaching 5000 cGy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I- Celecoxib | Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy | 1.42 units on a scale | Standard Deviation 0.67 |
| II- Placebo | Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy | 1.36 units on a scale | Standard Deviation 0.88 |
Secondary
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
Time frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)
Population: Only subjects who were still taking the study drug (celecoxib or placebo) when cumulative radiation dose of 5000 cGy was reached are included in this analysis (19 of 20 in each group were analyzed).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I- Celecoxib | Evaluation of Pain Severity at 5000 cGy Radiation | 4.47 units on a scale | Standard Deviation 2.82 |
| II- Placebo | Evaluation of Pain Severity at 5000 cGy Radiation | 3.70 units on a scale | Standard Deviation 3.2 |