Overview

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

Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Analgesics, Opioid
Hydrocodone
Hydromorphone
Levorphanol
Morphine
Oxycodone
Oxymorphone
Criteria
Inclusion Criteria:

- Patients seen in the SCC or Pain Clinic with a diagnosis of cancer with or without
evidence of metastatic disease

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

- Age 18 or older

- Able to complete study assessments

- Individual is willing to sign written informed consent

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

- Patients who are local and able to follow-up in the SCC or Pain Clinic within 30 days
if necessary

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 3

Exclusion Criteria:

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

- Renal insufficiency defined as estimated glomerular filtration rate of < 60

- Hepatic insufficiency defined as transaminitis (aspartate aminotransferase [AST] or
alanine aminotransferase [ALT] > 3 times the highest normal value) or
hyperbilirubinemia of > 1.5 times the highest normal value

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

- Presence of neuropathic pain as a primary pain syndrome

- Non-malignant pain

- 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; Pain Clinic: Screener and Opioid Assessment for Patients with Pain (SOAPP)
score of 7 or higher. In the unlikely event that CAGE-AID or SOAPP is not present in
patient's chart, a CAGE-AID questionnaire will be administered after obtaining verbal
consent for screening

- Patients receiving methadone due to reasons such as long and variable half-life

- Patients receiving scheduled benzodiazepines due to the risk of excessive sedation

- Patients with a MEDD of > 300

- Unable or unwilling to sign consent