Oral MucositisPhase 2NCT00698204

Cox-2 Inhibition in Radiation-induced Oral Mucositis

A Phase 2 study testing celecoxib in people with Oral Mucositis, run by UConn Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Oral Mucositis
What is being tested?: celecoxib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 2 sitesUnited States
Study dates: Jul 2003to Dec 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Connecticut Health Center
Farmington, Connecticut, 06030-1605
Hartford Hospital
Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis

Conditions: Oral Mucositis
Being tested: celecoxib, placebo
Keywords: Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis
Medical subject headings: Stomatitis, Mucositis, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

celecoxibDrug
Also called Celebrex
Subject was asked to take celecoxib each day that radiation therapy was given.
placeboDrug
Subject was asked to take placebo each day that radiation therapy was given.

Study groups in NCT00698204
Study group	Role	What they receive
I- Celecoxib	Experimental	Not described Receives: Drug: celecoxib
II	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 weeks from start of radiation therapy (5000 cGy)

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2003Dec 2013

First posted17 Jun 2008 (estimated)
Study startJul 2003
Primary completionSep 2012
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oral MucositisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00698204
Sponsor's protocol ID: IRB 03 -157- 2
Other IDs: GCRC 487, COXAON-0509-150, K23DE016946-05
Status last verified: May 2014
First submitted: 12 Jun 2008
Last updated: 5 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25151488

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)

All Oral Mucositis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
ClinicalTrials.gov ID: NCT00698204
Acronym / sponsor ID: IRB 03 -157- 2
Conditions: Oral Mucositis
Keywords: Mucositis, Head and Neck Cancer, Head and Neck Neoplasms, Stomatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR), Pfizer
Study start: Jul 2003
Primary completion: Sep 2012 (actual)
Study completion: Dec 2013 (actual)
First posted: 17 Jun 2008 (estimated)
Results: Posted 5 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
I- Celecoxib	Experimental	Drug: celecoxib
II	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
celecoxibAlso: CelebrexSubject was asked to take celecoxib each day that radiation therapy was given.	Drug	I- Celecoxib
placeboSubject was asked to take placebo each day that radiation therapy was given.	Drug	II

Primary outcome

Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy
Time frame: 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.

1 secondary outcome

Evaluation of Pain Severity at 5000 cGy Radiation
Time frame: 5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)

Results and safety

Results posted to the registry on 5 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I- Celecoxib	20	19
II- Placebo	20	20

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

Time frame: 5 weeks from start of radiation therapy (5000 cGy). Mean (Standard Deviation). Unit: units on a scale

Measure	I- Celecoxib n = 19	II- Placebo n = 20
Value	1.42 (.67)	1.36 (.88)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the date of Informed Consent through 30 days after the last study intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I- Celecoxib	6 of 20 (30%)	1 of 20 (5%)	Not reported
II- Placebo	5 of 20 (25%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25151488Lalla 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.

Related trials for Oral Mucositis

Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rajesh V Lalla, DDS, Ph.D, CCRP principal investigator

UConn Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib in people with Oral Mucositis, run by UConn Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy (time frame: 5 weeks from start of radiation therapy (5000 cGy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00698204, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.