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Patients receive levorphanol 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.

Questionnaire Administration

Akhila S Reddy

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.

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.

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

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

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.

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.

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.

Will be rated using the Opioid Side Effect Scale on xerostmia, nauseas, constipation, drowsiness and confusion daily from day 0 to day 10 +/-1 and on day 30 +/- 3.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Neoplasms

Abdominal Neoplasms

Tramadol

In this group, you will be given 5 times the amount of opioid medication you needed on your last day in the hospital. You would then use this supply plus standard non-narcotic pain medications.

The total amount of opioid medication you needed on your last day in the hospital to set a maximum number of opioid medications at discharge (up to 30).

Ching-Wei D Tzeng, MD

To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.

Primary Objectives:

The co-primary objectives of this study are as follows:

1. To determine differences in the initial OME prescribed upon discharge between each algorithm/model.

1. To determine OME usage by day 14 after hospital discharge.

Secondary Objectives:

Secondary objectives are as follows:

1. To determine rates of patients with zero OME upon discharge.
2. To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
3. To determine number of unused or leftover pills at 15- and 30-days post- operation
4. To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation
5. To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use
6. To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation.
7. To determine patient satisfaction with either prescribing model.

5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer	NCT03579446	Hematopoietic a... Malignant Solid... Metastatic Mali...	Hydrocodone Hydromorphone Levorphanol Morphine Oxycodone Oxymorphone Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer	NCT03579446	Hematopoietic a... Malignant Solid... Metastatic Mali...	Hydrocodone Hydromorphone Levorphanol Morphine Oxycodone Oxymorphone Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial	NCT06232577	Intra-abdominal...	Hydrocodone Tramadol Oxycodone	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hydrocodone

Every month we try and update this database with for hydrocodone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hydrocodone

Every month we try and update this database with for hydrocodone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hydrocodone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.