Levorphanol for Pain in Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAkhila S Reddy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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

I am 18 years old or older.

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

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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

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

I am currently taking methadone.

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Treatment Details

Interventions

Levorphanol (Opioid)

Trial OverviewThe 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.

Participant Groups

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.