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

Malignant Solid Neoplasm Clinical Trial

Official title:
Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study

Clinical Trial 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.

Clinical Trial Description

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. III. To determine the association between the opioid rotation ratio from MEDD to levorphanol and baseline MEDD prior to opioid rotation. IV. Measure levorphanol related side effects using the opioid side effect scale at day 10 +/- 1 of starting levorphanol. V. Determine what percentage of patients rotated to levorphanol achieve their personalized pain goal. VI. Determine the predictors of successful opioid rotation from other opioids to levorphanol. OUTLINE: Patients receive levorphanol orally (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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03579446
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date November 29, 2018
Completion date June 15, 2026
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