Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer
NCT04221165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2024-02-28
Summary
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.
Conditions
- Head and Neck Cancer
- Radiation-Induced Mucositis
Interventions
- DRUG
-
Opioids
Opioids will be prescribed as per institutional standards.
- DRUG
-
PAiN - multimodal analgesia
PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium
Sponsors & Collaborators
-
Ontario Institute for Cancer Research
collaborator OTHER -
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
lead OTHER
Principal Investigators
-
David Palma, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-04
- Primary Completion
- 2023-09-15
- Completion
- 2023-09-15
Countries
- Canada
Study Locations
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