A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Differences in the mean pain intensity score as assessed by the daily average Numeric Rating Scale (NRS) pain score during the week given acetaminophen compared with the daily average NRS pain score during the week given placebo
研究概览
简要总结
Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients demonstrated better pain control without an increase in side effects. This study will determine if regular acetaminophen improves pain control when added to strong opioids in patients with cancer pain.
详细描述
Aim:
To assess whether regular oral acetaminophen can reduce pain in cancer patients already on a strong opioid regimen.
Rationale:
It is estimated that 75% of people with advanced cancer suffer significant pain. Many of these people continue to have pain despite being on strong opioids. The rationale behind adding an additional analgesic with a different mechanism of action is to attempt to improve analgesia without increasing side effects.
Overview:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients diagnosed with malignancy who have persistent pain which is believed by the investigator to be due to their cancer, and whose analgesic regimen has been stabilised on > 60mg of morphine equivalents/day.
- •Age > 18 years
- •Performance status of 0-2 by the European Co-operative Oncology Group (ECOG) Performance Scale
- •Sufficient English skills to be able to complete the daily diary, BPI and to understand the consent form
- •Signed informed consent
排除标准
- •Patient has no pain (0/10 on NRS).
- •Patients with severe pain are excluded, however once their pain control is optimised they are eligible.
- •Patient has received radiation therapy in the six weeks prior to commencing the study or is likely to require radiotherapy during the study period.
- •Patient has commenced, or had dose modifications, to either non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids in the week prior to commencing the study, or during the two-week study period.
- •Patient has commenced chemotherapy or hormone therapy in the 4 weeks prior to the study or is expected to commence chemotherapy or hormonotherapy during the study period. Patients who are stable on long-term chemotherapy or hormones are eligible for this study. Patients who receive high dose steroids as antiemetics with their chemotherapy are eligible providing they are not receiving the steroids during the study period.
- •Patient has a contraindication to acetaminophen.
- •Use of acetaminophen in the 48 hours prior to commencement of the study period.
- •Abnormal laboratory values:
- •Absolute neutrophil count < 1.5 X 10^9/L and white blood cell (WBC) count < 3 X 10^9/L
- •Platelet count < 100 X 10^9/L
- •Liver transaminases > 2.5 X upper limit of normal
- •Bilirubin > 1.5 X upper limit of normal
- •Creatinine > 1.5 X upper limit of normal
研究组 & 干预措施
A, 1, acetaminophen
acetaminophen
干预措施: acetaminophen (Drug)
B placebo
placebo PO qid
干预措施: placebo, sugar pill (Drug)
结局指标
主要结局
Differences in the mean pain intensity score as assessed by the daily average Numeric Rating Scale (NRS) pain score during the week given acetaminophen compared with the daily average NRS pain score during the week given placebo
时间窗: post period 2
Patient preference for the acetaminophen or the placebo arm as assessed by asking the patient whether he/she preferred treatment period 1 or treatment period 2
时间窗: Post completion of period 2
次要结局
- Pain relief obtained in each treatment period(post period 2)
- Effect of pain on functional ability(post period 2)
- constipation(post period 2)
- overall sense of well being(post period 2)
- cold sweats(post period 2)
- Symptoms possibly associated with acetaminophen use for each period using an NRS: feeling sick (nausea and vomiting)(post period 2)
- Strength of preference for acetaminophen versus placebo on a 5-point scale(post period 2)
- drowsiness(post period 2)
- Total analgesic consumption in each treatment period(post period 2)
- Proportion of patients who had a preference for acetaminophen who perceived the improvement warranted taking the additional tablets(post period 2)
- Proportion of patients having a clinically significant improvement in pain (defined as an improvement in mean NRS of at least 33% during the week taking acetaminophen)(post period 2)
- Best and worst pain scores for each treatment period(post period 2)