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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
49
Opioids will be prescribed as per institutional standards.
PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
Average Pain Rating measured on the 11 Numeric Rating Scale
Average pain rating during the last 7 days of radiation therapy, as reported by the patient on the 11-Numeric Rating Scale (11-NRS). On the 11-NRS, zero (0) is no pain, and ten (10) is the worst possible pain.
Time frame: Approximately 2 years and 3 months
Average Weekly Opioid Use
The average weekly total opioid dose in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment.
Time frame: Approximately 2 years and 4 months
Duration of Opioid Requirement
The time from the start of opioid treatment after randomization to the time of stopping opioid analgesia, in days.
Time frame: Approximately 2 years and 6 months
Average Daily 11-Numeric Rating Scale for Pain
Average pain rating from the time of randomization until 6 weeks after completion of radiation treatment, as reported by the patient on the 11-Numeric Rating Scale (11-NRS). On the 11-NRS, zero (0) is no pain, and ten (10) is the worst possible pain.
Time frame: Approximately 2 years and 4 months
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 reported by the patient, will be assessed using the EORTC QLQ-C30 validated questionnaire. Responses regarding function and symptoms are on a scale of 1 (not at all) to 4 (very much). Also included are questions about overall health and quality of life. Responses are on a scale of 1 (very poor) to 7 (excellent).
Time frame: Approximately 24 months, 27 months, and 30 months
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)
Quality of life, as reported by the patient, will be assessed using the EORTC QLQ-HN 43 validated questionnaire. Responses regarding symptoms or problems are on a scale of 1 (not at all) to 4 (very much). This questionnaire is specifically for patients with head and neck cancer.
Time frame: Approximately 24 months, 27 months, and 30 months
Average Weekly Opioids Dispensed
The average weekly total opioid dose dispensed by the pharmacy in oral morphine equivalent dosing from randomization to 6 weeks after completion of radiation treatment.
Time frame: Approximately 2 years and 4 months
Hospital Admissions
Hospital admissions for febrile neutropenia, serious infection requiring intravenous antibiotics, gastrointestinal bleeding, myocardial infarction, stroke, and acute kidney injury.
Time frame: Approximately 27 months and 30 months
Time to Feeding Tube Insertion
The time to feeding tube insertion (e.g. gastrostomy-tube or nasogastric-tube) after randomization, in days.
Time frame: Approximately 2 years and 3 months
Weight Loss
Weight loss from randomization to the end of radiation treatment.
Time frame: Approximately 2 years and 3 months
Rates of Common Terminology Criteria for Adverse Events Toxicities
Rates of pre-specified Common Terminology Criteria for Adverse Events (CTCAE) toxicities.
Time frame: Approximately 2 years and 6 months
Treatment Interruptions
Number of participants with radiation of chemotherapy treatment interruptions.
Time frame: Approximately 2 years and 6 months
Death
Number of participants who die during or within 3 months after completion of radiation treatment.
Time frame: Approximately 2 years and 6 months
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