Clinical trial NCT03579446: Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer
Official title: Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol
timeFrame: Day 10 or any day after 2 days of rotation to levorphanol
Secondary outcomes:
measure: Opioid rotation ratio (ORR)
timeFrame: Up to 30 days
measure: Change of Edmonton Symptom Assessment Scale (ESAS) pain score
timeFrame: Baseline up to day 10 or any day after 2 days of rotation to levorphanol
measure: Incidence of levorphanol related side effects
timeFrame: Up to day 30
measure: Personalized pain goal (PPG)
timeFrame: Up to day 30
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Akhila S Reddy
role: PRINCIPAL_INVESTIGATOR
References: