Levorphanol for Pain in Cancer

Overseen By Akhila Reddy

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Strong oral opioids

Must not be taking: Methadone, Benzodiazepines

Disqualifiers: Cognitive impairment, Renal insufficiency, Hepatic insufficiency, Neuropathic pain, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

43 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are currently being treated with strong oral opioids like morphine or oxycodone. If you are on methadone or scheduled benzodiazepines, you cannot participate in the trial.

What data supports the effectiveness of the drug Levorphanol for pain in cancer?

Levorphanol has been shown to be effective in managing severe pain in cancer patients, including those with neuropathic pain that did not respond to other treatments. It has a unique profile that makes it suitable for treating various types of pain, and it has been effective in cases where other opioids failed. ^{1 2 3 4 5}

Is Levorphanol safe for use in humans?

Opioids, including Levorphanol, are commonly used to manage cancer-related pain, but they can have side effects and may affect health outcomes like survival. It's important to use them carefully under medical supervision to balance pain relief with potential risks. ^{6 7 8 9 10}

How is the drug levorphanol unique for treating cancer pain?

Levorphanol is unique because it acts on multiple pain pathways, including blocking NMDA receptors and activating various opioid receptors, which can make it effective for pain types that don't respond well to other opioids. It also has minimal drug interactions and doesn't affect the heart's QT interval, offering a potentially safer profile compared to other long-acting opioids like methadone. ^{1 2 3 4 5}

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.

Research Team

Akhila S Reddy

Principal Investigator

M.D. Anderson Cancer Center

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 used to opioids, taking 60 mg or more daily.

Individual is willing to sign written informed consent

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive levorphanol orally every 8 or 12 hours for 30 days, with additional opioid regimen for breakthrough pain

4 weeks

Daily monitoring for the first 10 days, then on day 30

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may continue levorphanol for an additional 6-8 months if determined by the Principal Investigator

6-8 months

Treatment Details

Interventions

• Levorphanol

Trial Overview 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.

Participant Groups

Group I: Supportive care (levorphanol, opioid regimen) Experimental Treatment 7 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Levorphanol for excruciating pain from oral cancer: a case report. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Levorphanol as a Second Line Opioid in Cancer Patients Presenting to an Outpatient Supportive Care Center: An Open-label Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Levorphanol for Treatment of Intractable Neuropathic Pain in Cancer Patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Characterization of Levorphanol, a G-Protein Biased Opioid Analgesic. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Levorphanol use: past, present and future. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Principles of opioid use in cancer pain. [2014]

7. Germany pubmed.ncbi.nlm.nih.gov

Impact of opioid use on health care utilization and survival in patients with newly diagnosed stage IV malignancies. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Complex Balance between Analgesic Efficacy, Change of Dose and Safety Profile Over Time, in Cancer Patients Treated with Opioids: Providing the Clinicians with an Evaluation Tool. [2020]

9. China pubmed.ncbi.nlm.nih.gov

Preliminary exploration on the role of clinical pharmacists in cancer pain pharmacotherapy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Establishment of Personalized Pain Goals in Oncology Patients to Improve Care and Decrease Costs. [2018]