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Opioid
Opioid Therapy vs Multimodal Analgesia for Head and Neck Cancer
Phase 2
Waitlist Available
Led By David Palma, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months, 27 months, and 30 months
Awards & highlights
Study Summary
This trial compares pain relief, quality of life, and other outcomes for patients taking opioids alone versus those taking a combination of three drugs.
Eligible Conditions
- Head and Neck Cancers
- Mucositis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months, 27 months, and 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months, 27 months, and 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Pain Rating measured on the 11 Numeric Rating Scale
Secondary outcome measures
Average Daily 11-Numeric Rating Scale for Pain
Average Weekly Opioid Use
Average Weekly Opioids Dispensed
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal AnalgesiaExperimental Treatment1 Intervention
Pregabalin (50 mg to 300 mg, oral, twice daily), acetaminophen (1000 mg, oral, 3 times per day), naproxen 250 mg to 500 mg, oral, twice daily), and pantoprazole magnesium (40 mg, oral, daily)
Group II: Opioid AnalgesiaActive Control1 Intervention
Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PAiN - multimodal analgesia
2020
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
658 Previous Clinical Trials
413,609 Total Patients Enrolled
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
9,136 Total Patients Enrolled
David Palma, MDPrincipal InvestigatorLawson Health Research Institute
5 Previous Clinical Trials
422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another active cancer at the same time.You are currently receiving or planning to receive high-dose radiation treatment for cancer.You have a mental health condition that needs medication to be managed.You have a confirmed allergy to acetaminophen, NSAIDs, pregabalin, or opioids.You have a history of or are currently struggling with addiction to drugs or alcohol.You take medicine every day to prevent seizures or treat depression.You have a history of bleeding in your stomach or intestines.You are expected to live for at least 6 more months.You have moderate to severe pain (rated 4/10 on a pain scale) in your mouth or throat, which is not caused by a current oral infection.You have a known condition that causes problems with bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid Analgesia
- Group 2: Multimodal Analgesia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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