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Clinical Trial Summary

The goal of this clinical research study is to learn about how well levorphanol can control cancer pain.

This is an investigational study. Levorphanol is FDA approved and commercially available for the treatment of pain. It is investigational to learn about how helpful it is in treating pain in cancer patients.

Up to 86 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Trial Description


Primary Objective:

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

Secondary Objectives:

1. 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). ORR will be calculated on day 10 +/- 1 as levorphanol mg (day 10 +/- 1) / MEDD mg (day 0) for each patient.

2. 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.

3. To determine the association between the opioid rotation ratio from MEDD to levorphanol and baseline MEDD prior to opioid rotation.

4. Measure levorphanol related side effects using the Opioid Side Effect Scale at day 10 +/- 1 of starting Levorphanol.

5. Determine what percentage of patients rotated to levorphanol achieve their personalized pain goal.

6. Determine the predictors of successful opioid rotation from other opioids to levorphanol ;

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
Status Recruiting
Phase Early Phase 1
Start date November 29, 2018
Completion date January 16, 2020

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