Methadone to Treat Painful Chemotherapy-induced Peripheral Neuropathy

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy induced peripheral neuropathy (CIPN) is a painful and disabling nerve pain that can be caused from common types of chemotherapy used to treat cancer. It can affect up to 70% of people who receive chemotherapy for months or even life-long. CIPN causes "glove-and-stocking" distribution of nerve-pain, weakness, lower quality of life, lower ability to do day to day tasks such as walking and writing, and other symptoms.

Duloxetine is the only recommended medication by national and international groups such as the American Society of Oncology to treat painful CIPN. However, studies show it only has small benefit; for example, the largest study showed it only reduces pain by 0.73 out of 10 points compared to placebo.

Another promising medication in theory and practice is methadone. It is a very well studied and commonly used pain medication from a class called opioids. However, it does have unique qualities that make it more effective to treat nerve pain when compared to other opioids like morphine and fentanyl. Furthermore, studies show it may develop less tolerance in the body over time when compared to other opioids; this is helpful as many develop lifelong CIPN and therefore may benefit from lifelong pain medication. Methadone has not been studied in CIPN.

This study is a pilot clinical trial to assess the ability of methadone to lower the pain caused by CIPN. It will help determine if it is feasible (ie. a good idea) to conduct a much larger study to absolutely determine if methadone is able to treat painful CIPN. In this pilot study, participants will receive methadone three times a day for 5 weeks. They will be followed virtually or in-person weekly for 5 weeks where they will answer brief questionnaires which will help determine the effect of their treatment on their pain and their dose will increase until their pain is hopefully controlled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: British Columbia Cancer Agency
• Treatments: Methadone

Criteria

Inclusion Criteria:

• Age >18 years old

• Estimated life expectancy greater than 12 weeks

• Opioid naïve or oral morphine equivalent use <60 mg/day

• Greater than grade 1 CIPN based on NCI Common Toxicity Criteria for Adverse Events version 5.0 grading scale

• >3/10 average CIPN-related neuropathic pain lasting ≥3 months beyond chemotherapy completion. Furthermore, participants require

• Any cancer diagnosis

• Treatment with at least one of the following neurotoxic chemotherapies: oxaliplatin, carboplatin, cisplatin, paclitaxel, docetaxel, or nab-paclitaxel.

• Co-analgesics have been stable for >2 weeks.

Exclusion Criteria:

Participants with a documented history:

• Other causes of peripheral neuropathy

• Leptomeningeal disease

• Severe depression

• Suicidality

• Bipolar disease or psychotic disorder

• Alcohol or substance abuse

• Major eating disorder

• Markedly abnormal renal or liver function tests within last 90 days

• Elevated QTC within last 90 days

• Pregnant or lactating patients

• Inability to take oral medications

• Known allergy to methadone.