Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Participant Pain Severity Score Measured Using Brief Pain Inventory
研究概览
简要总结
Primary Aims:
- To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 12-week treatment period in patients with advanced cancer. Previous studies have demonstrated consistent improvement of pain control after opioid rotation from morphine to methadone. In addition, the pilot study showed that there was a trend towards lower pain intensity when methadone used as first line opioid as compared to morphine. Researchers postulate that due to its superior analgesic effects, methadone will result in better pain control over time as compared to morphine.
- To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced frequency of neurotoxicity, dose escalation and treatment failure over a 12-week treatment period. Previous studies have demonstrated that patients develop increased pain or neurotoxicity after chronic use of morphine and require frequent opioid escalation. Researchers postulate that methadone will demonstrate lower opioid induced neurotoxicity, less frequent dose escalation and less treatment failure over 12-week treatment period as compared to morphine.
Secondary Aim:
-To perform an economic evaluation, comparing the costs and clinical benefits of methadone and morphine. Researchers will perform an evaluation that incorporates both treatment and potential "downstream" costs, as well as an examination of clinical benefits that incorporate preferences, to perform an appropriate economic comparison. We postulate that methadone and its associated costs will be cheaper than morphine. However, if one strategy is both more expensive and clinically superior than the other, researchers are prepared to perform an incremental cost-effectiveness analysis. In that case, researchers expect to show that the greater pharmaceutical costs involved with morphine will make its use not be a cost-effective strategy.
详细描述
STUDY DRUGS:
MORPHINE is recommended as the first choice of strong pain killers by the World Health Organization Pain Relief Guidelines.
METHADONE is recommended as the second choice of strong pain killers.
SCREENING TESTS:
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Patient has pain caused by advanced cancer (local recurrence or metastatic disease)
- •Patient reporting average pain score for the last 24 hours is >/= 4 on a numerical scale from 0 to 10 (0= no pain, 10=the worst possible pain).
- •Patient is receiving mild opioids (e.g. propoxyphene, codeine, tramadol, hydrocodone), mixed agonist/antagonist (e.g. buprenorphine) or no opioids.
- •Patient requires initiation of strong opioid for cancer pain.
- •Patient has the ability to receive morphine or methadone orally.
- •Patient has no known allergy or severe toxicity to morphine or morphine-like drugs (e.g. hydromorphone, oxycodone, oxymorphone, codeine, hydrocodone, levorphanol), or methadone or methadone-like drug (e.g. propoxyphene).
- •Patient has normal cognition defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit.
- •Patient has normal renal function (creatinine and blood urea nitrogen (BUN) within normal limits) </= 4 weeks of study entry.
- •Patient's performance status (ECOG) is 3 or less.
- •Patient is willing to sign written informed consent.
- •Patient is 18 years of age or older.
- •Patient is able to return to clinic for evaluation by physician day 8 , 15 , 29, 57 and 85 ( +/- 3 days) during study period.
排除标准
- •Patient has concurrent strong opioid for cancer pain, such as morphine, hydromorphone, oxycodone, meperidine, fentanyl, oral transmucosal fentanyl citrate (OTFC), sufentanil, methadone, levorphanol, transdermal fentanyl.
- •Patient is receiving radiation therapy for pain control.
- •Patient is receiving drugs that interacting with methadone, such as (delavirdine, fluconazole, fluvoxamine, bravavir, amprenavir, efavirenz, lopinavir, nelfinavir, nevirapine, carbamazepine, dexamethasone (Patients receiving short term chemotherapy-related doses are permitted) , phenytoin, rifampin, or grapefruit,).
- •Patients are determined incapable of completing the evaluation forms.
- •Severe hypotension, acute or severe asthma, paralytic ileus, gastrointestinal obstruction, severe respiratory depression.
研究组 & 干预措施
Morphine Capsule
Morphine 15 mg slow release orally every 12 hours + additional doses as needed
干预措施: Morphine (Drug)
Methadone Capsule
Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
干预措施: Methadone (Drug)
结局指标
主要结局
Participant Pain Severity Score Measured Using Brief Pain Inventory
时间窗: Comparing baseline and pain scores at 4 weeks (+/- 3 days)
Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its "worst", "least", "average " and "now". The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words "no pain' at the 0 end and "pain as bad as you can imagine" at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer.
次要结局
未报告次要终点