Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer

Official Title

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

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.

Trial Description

Primary Outcome:

• Average Pain Rating measured on the 11 Numeric Rating Scale

Secondary Outcome:

• Average Weekly Opioid Use
• Duration of Opioid Requirement
• Average Daily 11-Numeric Rating Scale for Pain
• Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
• Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head & Neck 43 (EORTC QLQ-HN 43)
• Average Weekly Opioids Dispensed
• Hospital Admissions
• Time to Feeding Tube Insertion
• Weight Loss
• Rates of Common Terminology Criteria for Adverse Events Toxicities
• Treatment Interruptions
• Death

A significant proportion of patients undergoing radiation therapy alone or chemotherapy and radiation therapy 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.

View this trial on ClinicalTrials.gov