Trial Outcomes & Findings for Cox-2 Inhibition in Radiation-induced Oral Mucositis (NCT NCT00698204)

Last Updated: 2014-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

5 weeks from start of radiation therapy (5000 cGy)

Results posted on

2014-06-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	I- Celecoxib celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	I- Celecoxib celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Cox-2 Inhibition in Radiation-induced Oral Mucositis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I- Celecoxib n=20 Participants celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.	II- Placebo n=20 Participants placebo: Subject was randomized to take placebo each day that radiation therapy was given.	Total n=40 Participants Total of all reporting groups
Age, Continuous	53.15 years n=93 Participants	56.00 years n=4 Participants	54.58 years n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	19 Participants n=4 Participants	39 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=93 Participants	18 Participants n=4 Participants	38 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	I- Celecoxib n=19 Participants celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo n=20 Participants placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy	1.42 units on a scale Standard Deviation .67	1.36 units on a scale Standard Deviation .88

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	I- Celecoxib n=19 Participants celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo n=19 Participants placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Evaluation of Pain Severity at 5000 cGy Radiation	4.47 units on a scale Standard Deviation 2.82	3.70 units on a scale Standard Deviation 3.20

Adverse Events

I- Celecoxib

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

II- Placebo

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	I- Celecoxib n=20 participants at risk celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo n=20 participants at risk placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Blood and lymphatic system disorders Electrolyte abnormality	0.00% 0/20 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.
Blood and lymphatic system disorders Febrile neutropenia	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.
General disorders Fever	15.0% 3/20 • Number of events 3 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	15.0% 3/20 • Number of events 3 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.
Respiratory, thoracic and mediastinal disorders Myocardial infarction	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	0.00% 0/20 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.
Gastrointestinal disorders Nausea/vomiting	15.0% 3/20 • Number of events 8 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	10.0% 2/20 • Number of events 2 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	0.00% 0/20 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.

Other adverse events

Other adverse events
Measure	I- Celecoxib n=20 participants at risk celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).	II- Placebo n=20 participants at risk placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
Immune system disorders pruritus	5.0% 1/20 • Number of events 1 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.	0.00% 0/20 • Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention. 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.

Additional Information

Dr. Rajesh V. Lalla

University of Connecticut Health Center

Phone: 860-679-8007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place