Cox-2 Inhibition in Radiation-induced Oral Mucositis

NCT00698204 | Completed Phase 2 Results DMC

• 4 other identifiers: IRB 03 -157- 2GCRC 487COXAON-0509-150K23DE016946-05
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Mucositis

Keywords

Mucositis; Head and Neck Cancer; Head and Neck Neoplasms; Stomatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  5 weeks from start of radiation therapy (5000 cGy)

Secondary Outcomes (1)

• Evaluation of Pain Severity at 5000 cGy Radiation

  5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)

Study Arms (2)

I- Celecoxib

EXPERIMENTAL

Drug: celecoxib

II

PLACEBO COMPARATOR

Drug: placebo

Interventions

celecoxib DRUG

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

Also known as: Celebrex

I- Celecoxib

placebo DRUG

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

II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• Pfizer: collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030-1605, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Related Publications (1)

• 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.

  PMID: 25151488 DERIVED

MeSH Terms

Conditions

Stomatitis; Mucositis; Head and Neck Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Rajesh V. Lalla
• Organization: University of Connecticut Health Center

lalla@uchc.edu

860-679-8007

Study Officials

• Rajesh V Lalla, DDS, Ph.D, CCRP

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Oral Medicine

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 17, 2008
• Study Start: July 1, 2003
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 5, 2014
• Results First Posted: June 5, 2014

Record last verified: 2014-05

Locations

US (2)