Opioid Therapy vs Multimodal Analgesia for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by David Palma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the daily pain level scores for patients taking opioids alone for pain relief, compared with those treated by multimodal analgesia with three medications: pregabalin, naproxen, and acetaminophen, with the ability to switch over to opioid medications if needed. In addition to pain level scores, this study will compare opioid use (length of time and doses taken), quality of life, admissions to hospital, feeding tube requirements, weight loss, and treatment interruptions between these two analgesic regimens.

Research Team

David Palma, MD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

Inclusion Criteria

Age 18 or older

Willing to provide consent

Ability to sign consent without requirement for a substitute decision maker

Exclusion Criteria

You have another active cancer at the same time.

Pregnant or lactating women

Regular systemic steroid use

Treatment Details

Interventions

• Opioids (Opioid)
• PAiN - multimodal analgesia (Multimodal Analgesia)

Participant Groups

Group I: Multimodal Analgesia Experimental Treatment 1 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 Analgesia Active Control 1 Intervention

Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Dr. Alex Barron

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Chief Executive Officer

Physiotherapy degree

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lisa Porter

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Roy Butler

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Chief Medical Officer

MD, PhD

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

Ontario Institute for Cancer Research

Collaborator

Trials

24

Recruited

9,200+