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Celecoxib for Advanced Head and Neck Cancer
Phase 2
Waitlist Available
Led By Richard Cannon, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status of >= 80
Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 or creatinine clearance >= 30 mL/min by Cockcroft-Gault
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial looks at whether adding celecoxib to standard care can decrease the time between surgery and radiation therapy for patients with advanced head and neck cancer.
Who is the study for?
This trial is for adults with advanced head and neck cancers, including those in the nasal area, oral cavity, oropharynx, larynx, and hypopharynx. Participants must be undergoing surgery followed by radiation therapy. They should have good physical function (Karnofsky score >=80), normal liver and kidney function tests, agree to use effective contraception if applicable, and not be on long-term opioids or have certain cardiovascular conditions.Check my eligibility
What is being tested?
The study is testing whether adding celecoxib—a drug approved for pain relief—to standard treatment can shorten the time between surgery and radiation therapy in patients with advanced head and neck cancer. The effectiveness of celecoxib will also be compared against a placebo while assessing quality-of-life through questionnaires.See study design
What are the potential side effects?
Celecoxib may cause side effects such as digestive issues like stomach ulcers or bleeding; heart problems including hypertension; allergic reactions especially in those allergic to NSAIDs or sulfonamides; kidney problems; increased risk of blood clots leading to stroke or heart attack.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out normal activities with minimal symptoms.
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My kidney function is at a safe level for the trial.
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I am using or will use effective birth control during and 5 days after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of days from surgery to the initiation of radiation and adjuvant therapy
Secondary outcome measures
Celecoxib
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
Assessment of the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Celecoxib ArmExperimental Treatment3 Interventions
Patients receive celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Group II: Placebo ArmPlacebo Group3 Interventions
Patients receive placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,095 Previous Clinical Trials
1,775,525 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
Richard Cannon, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your albumin level is higher than 3.5 grams per deciliter.Your blood potassium levels are normal.I have HIV with a detectable viral load in the last 6 months.My kidney function is at a safe level for the trial.I have been on opioids for pain management for at least 6 months.Your hemoglobin level is at least 10 grams per deciliter.I don't have another cancer that could affect this treatment's safety or results.You are allergic to celecoxib, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or sulfonamides.I have chronic hepatitis B or C with a detectable viral load.I am using or will use effective birth control during and 5 days after the study.My cancer is in an advanced stage and located in the head or neck area, and I am undergoing surgery followed by radiation.My cancer has spread or cannot be removed by surgery.I have stopped taking certain medications for enough time before starting treatment.I have a history of stroke, heart failure, severe stomach issues, asthma worsened by aspirin, or advanced kidney disease.I can carry out normal activities with minimal symptoms.I have had unusual reactions to medications like warfarin or phenytoin.Your total bilirubin level should be less than or equal to 2 mg/dL.My blood pressure is consistently high despite taking medication.I am willing to undergo radiation therapy after surgery if needed.I have recovered from previous treatment side effects, or they are minor and stable.I am willing to keep a diary of all painkillers I use during the trial.Your AST and ALT levels are not more than 2.5 times the normal limit.Women who can have babies need to have a negative pregnancy test before joining the study.My team recommends additional radiation after surgery, pending final pathology results.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Celecoxib Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what sorts of health concerns is Celecoxib usually prescribed?
"While typically used to mitigate pain, celecoxib can also be prescribed to patients suffering from primary dysmenorrhoea, rheumatoid arthritis, and ankylosing spondylitis."
Answered by AI
Is there a heightened risk for Celecoxib patients?
"While there is some clinical data supporting the safety of Celecoxib, none of it points to efficacy, so it received a score of 2."
Answered by AI
What is the total number of people taking part in this clinical trial?
"That is accurate, the information available on clinicaltrials.gov says that this study is currently looking for patients. This trial was first posted on 27th November 2019 and updated as recently as 9th June 2022. The study needs to recruit 60 patients from 1 site."
Answered by AI
Are new volunteers needed for this experiment?
"The clinical trial is currently enrolling 60 patients at 1 sites."
Answered by AI
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