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Clinical Trial Summary

This early phase I trial studies how well levorphanol works as a second line opioid in reducing pain in participants with cancer that may have spread to other places in the body. Levorphanol may work better in controlling cancer pain.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol on day 10 +/- 1 after rotation.

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).

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 on day 10 +/- 1 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:

Participants receive levorphanol orally (PO) every 8 or 12 hours for 30 days. Participants may receive opioid regimen including hydrocodone, morphine sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03579446
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Akhila Reddy
Phone 713-745-2668
Email CR_Study_Registration@mdanderson.org
Status Not yet recruiting
Phase Early Phase 1
Start date September 7, 2018
Completion date March 7, 2019

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