Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Average Pain Rating measured on the 11 Numeric Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing to provide consent
- •Histologically confirmed mucosal head and neck malignancy
- •Undergoing chemoradiotherapy or radiotherapy alone with a planned total radiation dose of 50 Gray (Gy) or greater
- •Eastern Co-operative Oncology Group (ECOG) performance status 0-2
- •Life expectancy > 6 months
- •Onset of 4/10 pain on the 11-Numeric Rating Scale that is localized to the mucosa of the mouth or throat, before or during radiation treatment, that is not caused by a current oral candidiasis infection.
- •Ability to take pills, either by mouth or crushed via NasoGastric (NG) tube or Gastrostomy tube (G-tube)
- •Ability to complete the study questionnaires and pain diary
- •Ability to sign consent without requirement for a substitute decision maker
排除标准
- •Skin and salivary gland malignancies
- •High daily opioid use at time of enrollment (defined as 30 mg oral morphine equivalent dose or higher)
- •Concurrent second active malignancy
- •Pregnant or lactating women
- •Psychological disorder requiring pharmacologic treatment
- •Regular systemic steroid use
- •Regular anticonvulsant or antidepressant use
- •Renal Impairment (defined as creatinine clearance < 60 mL/min)
- •Liver Dysfunction (defined as total bilirubin > 34.2 µmol/L)
- •Documented true allergy to acetaminophen, NSAIDs, pregabalin or opioids
- •History of upper gastrointestinal bleed
- •Known bleeding disorder
- •History of or current substance use disorder
研究组 & 干预措施
Multimodal Analgesia
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)
干预措施: PAiN - multimodal analgesia (Drug)
Opioid Analgesia
Opioids will be prescribed as per institutional standards. Examples of opioids are morphine and hydromorphone.
干预措施: Opioids (Drug)
结局指标
主要结局
Average Pain Rating measured on the 11 Numeric Rating Scale
时间窗: Approximately 2 years and 3 months
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.
次要结局
- Death(Approximately 2 years and 6 months)
- Average Weekly Opioid Use(Approximately 2 years and 4 months)
- Duration of Opioid Requirement(Approximately 2 years and 6 months)
- Average Daily 11-Numeric Rating Scale for Pain(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)(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)(Approximately 24 months, 27 months, and 30 months)
- Average Weekly Opioids Dispensed(Approximately 2 years and 4 months)
- Time to Feeding Tube Insertion(Approximately 2 years and 3 months)
- Weight Loss(Approximately 2 years and 3 months)
- Rates of Common Terminology Criteria for Adverse Events Toxicities(Approximately 2 years and 6 months)
- Treatment Interruptions(Approximately 2 years and 6 months)
- Hospital Admissions(Approximately 27 months and 30 months)