Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol
研究概览
简要总结
This early phase I trial studies how well levorphanol works as a second line opioid in reducing pain in patients with cancer that may have spread to other places in the body. Levorphanol may work better in controlling cancer pain.
详细描述
PRIMARY OBJECTIVE:
I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol at the primary end point.
SECONDARY OBJECTIVES:
I. To determine the median opioid rotation ratio (ORR) in patients undergoing successful opioid rotations from morphine equivalent daily dose (MEDD) to levorphanol in the Supportive Care Center (SCC) or Pain Clinic.
II. To determine the effect of levorphanol on cancer pain (as measured by change in Edmonton Symptom Assessment System's [ESAS] pain item from baseline) in cancer outpatients undergoing opioid rotation to levorphanol at the primary end point of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients seen in the SCC or Pain Clinic with a diagnosis of cancer with or without evidence of metastatic disease
- •Diagnosis of cancer related pain currently treated with first line strong oral opioid analgesics such as morphine, oxycodone, oxymorphone, hydromorphone or hydrocodone
- •Age 18 or older
- •Able to complete study assessments
- •Individual is willing to sign written informed consent
- •Patients who are classified as being opioid tolerant by receiving a baseline MEDD of >= 60 mg
- •Patients who are local and able to follow-up in the SCC or Pain Clinic within 30 days if necessary
- •Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
排除标准
- •Cognitive impairment with a Memorial Delirium Assessment Scale (MDAS) score of 7 or higher or diagnosed with neurocognitive impairment by the treating SCC or Pain Clinic physician
- •Renal insufficiency defined as estimated glomerular filtration rate of < 60
- •Hepatic insufficiency defined as transaminitis (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 times the highest normal value) or hyperbilirubinemia of > 1.5 times the highest normal value
- •Non-English speaking participants as not all assessments are validated in other languages
- •Presence of neuropathic pain as a primary pain syndrome
- •Non-malignant pain
- •Patients with history of alcohol or substance abuse by using Cut-down, Annoyed, Guilty, Eye-opener adapted to include Drug use questionnaire (CAGE-AID) score of 2 or higher; Pain Clinic: Screener and Opioid Assessment for Patients with Pain (SOAPP) score of 7 or higher. In the unlikely event that CAGE-AID or SOAPP is not present in patient's chart, a CAGE-AID questionnaire will be administered after obtaining verbal consent for screening
- •Patients receiving methadone due to reasons such as long and variable half-life
- •Patients receiving scheduled benzodiazepines due to the risk of excessive sedation
- •Patients with a MEDD of > 300
- •Unable or unwilling to sign consent
研究组 & 干预措施
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Hydrocodone (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Hydromorphone (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Levorphanol (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Morphine (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Oxycodone (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Oxymorphone (Drug)
Supportive care (levorphanol, opioid regimen)
Patients receive levorphanol PO every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine, hydromorphone, oxycodone, and oxymorphone for breakthrough pain. Patients may continue levorphanol for an additional 6-8 months if it is determined by the Principal Investigator the patient can continue.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol
时间窗: Day 10 or any day after 2 days of rotation to levorphanol
Bayesian methodology developed by Peter Thall will be used to monitor the study. This method decides whether levorphanol is promising relative to the standard medicine. Will estimate the proportion of successful opioid rotation along with a 95% confidence interval. Association between successful opioid rotation and demographic/clinical characteristics will be examined by Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will be employed to assess the effect of demographic/clinical characteristics on the presence of successful opioid rotation.
次要结局
- Opioid rotation ratio (ORR)(Up to 30 days)
- Personalized pain goal (PPG)(Up to day 30)
- Change of Edmonton Symptom Assessment Scale (ESAS) pain score(Baseline up to day 10 or any day after 2 days of rotation to levorphanol)
- Incidence of levorphanol related side effects(Up to day 30)