Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT03579446|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm Metastatic Malignant Neoplasm Pain||Drug: Hydrocodone Drug: Hydromorphone Drug: Hydromorphone Hydrochloride Drug: Levorphanol Drug: Morphine Drug: Morphine Sulfate Drug: Oxycodone Drug: Oxymorphone Drug: Oxymorphone Hydrochloride Other: Questionnaire Administration||Early Phase 1|
I. To determine the proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol on day 10 +/- 1 after rotation.
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 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.
Patients receive levorphanol orally (PO) every 8 or 12 hours for 30 days. Patients may receive opioid regimen including hydrocodone, morphine sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study|
|Actual Study Start Date :||November 29, 2018|
|Estimated Primary Completion Date :||January 16, 2020|
|Estimated Study Completion Date :||January 16, 2020|
Experimental: 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 sulfate, hydromorphone hydrochloride, oxycodone, and oxymorphone hydrochloride for breakthrough pain.
Drug: Hydromorphone Hydrochloride
Drug: Morphine Sulfate
Other Name: Oxycodone SR
Drug: Oxymorphone Hydrochloride
Other: Questionnaire Administration
- Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol [ Time Frame: Day 10 ]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.
- Opioid rotation ratio (ORR) [ Time Frame: Up to 30 days ]Will be calculated by levorphanol mg (day 10 +/- 1) over MEDD (day 0). ORR will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on ORR between/among patients' characteristics groups.
- Change of Edmonton Symptom Assessment Scale (ESAS) pain score [ Time Frame: Baseline to day 10 ]Pain score change will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Wilcoxon rank-sum test or Kruskal-Wallis test will be applied to examine the difference on pain score change between/among patients' characteristics groups. Since ESAS pain score will be measured daily from day 0 to day 10 +/- 1 and on day 30 +/- 3, mixed model will be applied to examine the differential changes over time for ESAS pain score, adjusting for other covariates of interest. ORR and baseline MEDD will be presented by scatter plots. Correlation will be assessed between levorphanol dose on day 10 +/- 1, ORR and baseline MEDD suing Pearson or Spearman correlation coefficient when appropriate. Linear regression models will be applied to estimate the linear association between levorphanoal dose on day 10 +/- 1, ORR and baseline MEDD.
- Incidence of levorphanol related side effects [ Time Frame: Up to day 30 ]Will be rated using the Opioid Side Effect Scale on xerostomia, nauseas, constipation, drowsiness and confusion daily from day 0 to day 10 +/-1 and on day 30 +/- 3.
- Personalized pain goal (PPG) [ Time Frame: Up to day 30 ]PPG will be summarized using standard descriptive statistics such as mean, standard deviation, median and range. Mixed model will be applied to examine the differential changes over time for opioid side effect scale, adjusting for other covariates of interest. The goal is not achieved if the PPG is lower than the ESAS pain score. Frequency and proportion of achieved goal will be summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579446
|Contact: Akhila Reddyfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Akhila S. Reddy 713-745-2668|
|Principal Investigator: Akhila S. Reddy|
|Principal Investigator:||Akhila S Reddy||M.D. Anderson Cancer Center|