Levorphanol as A Second Line Opioid in Reducing Pain in Participants With Cancer

Objectives:

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

Inclusion Criteria:

1. Patients seen in the SCC with a diagnosis of cancer with or without evidence of
metastatic disease

2. Diagnosis of cancer related pain currently treated with first line strong oral opioid
analgesics such as morphine, oxycodone, oxymorphone, hydromorphone or hydrocodone.

3. Age 18 or older

4. Able to complete study assessments

5. Individual is willing to sign written informed consent

6. Patients who are classified as being opioid tolerant by receiving a baseline MEDD of
>/= 60 mg

7. Patients who are local and able to follow-up in the SCC within 30 days if necessary

8. Eastern Cooperative Oncology Group (ECOG) Performance Status of
9. Able to swallow oral medication

Exclusion Criteria:

1. Cognitive impairment with a Memorial Delirium Assessment Scale (MDAS) score of 7 or
higher or diagnosed with neurocognitive impairment by the treating SCC physician.

2. Renal insufficiency defined as estimated Glomerular filtration rate of <60 or hepatic
insufficiency defined as transaminitis or hyperbilirubinemia of > 1.5 times the
highest normal value.

3. Non-English speaking participants as not all assessments are validated in other
languages.

4. Presence of pain primarily due to chemotherapy induced peripheral neuropathy

5. Non-malignant pain

6. Patients with history of alcohol or substance abuse by using Cut-down, Annoyed,
Guilty, Eye-opener adapted to include Drug use questionnaire (CAGE-AID) score of 2 or
higher

7. Patients receiving methadone or transdermal fentanyl due to reasons such as long and
variable half-life and transdermal rather than oral route for delivery of opioids.

8. Patients receiving scheduled benzodiazepines due to the risk of excessive sedation

9. Unable or unwilling to sign consent