A Phase 2 interventional study of celecoxib and placebo in Oral Mucositis, sponsored by UConn Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-06-05.
Sponsored by UConn Health · Phase 2, Interventional, and Prevention
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 43 is below the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: celecoxib
Drug: placebo
Subject was asked to take celecoxib each day that radiation therapy was given.
Also known as: Celebrex
Subject was asked to take placebo each day that radiation therapy was given.
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)
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)
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.
| Milestone | I- Celecoxib | II- Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| units on a scale | I- Celecoxib | II- Placebo |
|---|---|---|
| Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy | 1.42 ± .67 | 1.36 ± .88 |
Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable
| units on a scale | I- Celecoxib | II- Placebo |
|---|---|---|
| Evaluation of Pain Severity at 5000 cGy Radiation | 4.47 ± 2.82 | 3.70 ± 3.20 |
Collected over Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| I- Celecoxib | — | 6/20 (30%) | 1/20 (5%) |
| II- Placebo | — | 5/20 (25%) | 0/20 (0%) |
| Event | I- Celecoxib | II- Placebo |
|---|---|---|
| FeverGeneral disorders | 3/20 | 3/20 |
| Nausea/vomitingGastrointestinal disorders | 3/20 | 2/20 |
| Electrolyte abnormalityBlood and lymphatic system disorders | 0/20 | 1/20 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/20 | 1/20 |
| Myocardial infarctionRespiratory, thoracic and mediastinal disorders | 1/20 | 0/20 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/20 | 0/20 |
| Event | I- Celecoxib | II- Placebo |
|---|---|---|
| pruritusImmune system disorders | 1/20 | 0/20 |
Intent-to-treat analysis performed for 40 participants. Per-protocol analysis performed for the period in which individual participants were taking study medication (celecoxib or placebo).
| Age, Continuous(years) | I- Celecoxib | II- Placebo | Total |
|---|---|---|---|
| Mean | 53.15 (34 to 71) | 56.00 (36 to 69) | 54.58 (34 to 71) |
| Sex: Female, Male(Participants) | I- Celecoxib | II- Placebo | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 17 | 15 | 32 |
| Race (NIH/OMB)(Participants) | I- Celecoxib | II- Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 20 | 19 | 39 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | I- Celecoxib | II- Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 20 | 18 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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