Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Analgesics, Opioid; Hydrocodone; Hydromorphone; Levorphanol; Morphine; Oxycodone; Oxymorphone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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