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Levorphanol for Pain in Cancer

Phase < 1

Waitlist Available

Led By Akhila S Reddy

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

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

Must not have

Presence of neuropathic pain as a primary pain syndrome

Patients with a MEDD of > 300

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 10 or any day after 2 days of rotation to levorphanol

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether levorphanol can help reduce pain in cancer patients who have tried other opioids.

Who is the study for?

This trial is for adults with cancer pain currently managed by strong opioids like morphine or oxycodone. They must be opioid-tolerant, local to the clinic for follow-ups, able to complete assessments, and have an ECOG status of <=3. Excluded are those with renal or hepatic insufficiency, cognitive impairment, non-English speakers, non-cancer pain sufferers, substance abuse history, methadone users, primary neuropathic pain sufferers or high sedation risk.

What is being tested?

The study is testing levorphanol as a second line treatment for controlling cancer-related pain that may have spread in the body. It's an early phase I trial comparing levorphanol's effectiveness against other first line strong oral opioids through patient questionnaires and assessments.

What are the potential side effects?

Levorphanol can potentially cause side effects similar to other opioids such as nausea, vomiting, constipation, drowsiness and dizziness. There might also be risks of increased sedation when combined with certain medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am used to opioids, taking 60 mg or more daily.

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I can take care of myself but can't do heavy physical work.

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I am taking strong pain medication like morphine for my cancer pain.

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I can participate in all required study check-ups and tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main pain is due to nerve damage.

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I take more than 300 mg of morphine or its equivalent daily for pain.

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I am currently taking methadone.

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My kidney function is reduced with a filtration rate below 60.

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My liver tests are significantly higher than normal.

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I am taking benzodiazepines regularly due to risks of excessive sedation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 10 or any day after 2 days of rotation to levorphanol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 10 or any day after 2 days of rotation to levorphanol

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 10 or any day after 2 days of rotation to levorphanol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of successful opioid rotation (OR) from morphine equivalent daily dose (MEDD) to levorphanol

Secondary study objectives

Change of Edmonton Symptom Assessment Scale (ESAS) pain score

Incidence of levorphanol related side effects

Opioid rotation ratio (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (levorphanol, opioid regimen)Experimental Treatment7 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxymorphone

2016

Completed Phase 1

~27140

Morphine

2013

Completed Phase 4

~2230