Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

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

celecoxib

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

placebo

Rajesh V Lalla, DDS, Ph.D, CCRP

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.

Cox-2 Inhibition in Radiation-induced Oral Mucositis

Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

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.

Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable

National Institute of Dental and Craniofacial Research (NIDCR)

Pfizer

UConn Health

Associate Professor, Oral Medicine

All events reported as serious adverse events resulted in hospitalization of the participant during the period of study participation. All adverse events were reviewed by an independent Data and Safety Monitoring Board (DSMB) and were determined to be unrelated to use of celecoxib.

celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).

I- Celecoxib

placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).

II- Placebo

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

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

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

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).

Dr. Rajesh V. Lalla

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.

Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy

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).

Spots Global Cancer Trial Database for Cox-2 Inhibition in Radiation-induced Oral Mucositis

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