NCT04221165

Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer

Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A significant proportion of patients undergoing radiotherapy alone or chemotherapy and radiotherapy together for their head and neck cancer experience mucositis, which is severe pain in the mouth and throat caused by radiation treatment. Patients often enter a cycle of pain, difficulty swallowing, malnourishment, and reduced quality of life. This may translate into decreased oral intake requiring a feeding tube, and radiation or chemotherapy treatment breaks, which reduce the chance of tumour control and cure. Currently, opioid therapy is the cornerstone of head and neck cancer pain management. Although effective for pain relief, opioids can have side effects. As an alternative to opioid treatments, "multimodal analgesia" is a treatment using medications from different classes with different mechanisms of action. Examples of analgesic medications used for multimodal analgesia include medications similar to acetaminophen or ibuprofen, and others. The primary purpose of this study is to compare pain level scores of patients taking opioids versus patients taking multimodal analgesia.

Conditions

• Head and Neck Cancer
• Radiation-Induced Mucositis

Interventions

Type	Name	Description
DRUG	Opioids	Opioids will be prescribed as per institutional standards.
DRUG	PAiN - multimodal analgesia	PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2020-01-09
• Last updated: 2024-02-28

Locations

1 site across 1 country: Canada