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New treatment option for Chemotherapy-induced Peripheral Neuropathy
Official title Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05786599
What this study is testing
What is methadone?
methadone is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for chemotherapy-induced peripheral neuropathy.
Also referred to as metadol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chemotherapy induced peripheral neuropathy (CIPN) or nerve pain, is a painful and debilitating complication which can chronically affect up to 70% of patients who receive chemotherapy. It causes "glove-and-stocking" distribution of nerve-pain, weakness, and other debilitating symptoms.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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 CTCAE.
- \>3/10 average CIPN-related neuropathic pain lasting ≥3 months beyond chemotherapy completion.
You likely can't join if
- Other causes of peripheral neuropathy.
- The following psychiatric illnesses: severe depression, suicidality, bipolar disease or psychotic disorder, alcohol or substance use disorder, DSM V...
- The following medical illnesses: known or suspected mechanical gastrointestinal obstruction or any disease/conditions that affect bowel transit...
- Liver or renal dysfunction within the last 90 days as defined by MELD-Na score ≥17 and GFR ≤30 ml/min respectively.
- QTC \>499ms within last 90 days.
- Current pregnancy or lactation.
See the full eligibility 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 CTCAE.
- \>3/10 average CIPN-related neuropathic pain lasting ≥3 months beyond chemotherapy completion.
- A cancer diagnosis.
- Treatment with one of the following neurotoxic chemotherapies: platinums, taxanes, vinca alkaloids, bortezomib, or thalidomide.
- Other causes of peripheral neuropathy.
- The following psychiatric illnesses: severe depression, suicidality, bipolar disease or psychotic disorder, alcohol or substance use disorder, DSM V criteria eating disorder.
- The following medical illnesses: known or suspected mechanical gastrointestinal obstruction or any disease/conditions that affect bowel transit, suspected surgical abdomen, acute or severe asthma, COPD, acute...
- Liver or renal dysfunction within the last 90 days as defined by MELD-Na score ≥17 and GFR ≤30 ml/min respectively.
- QTC \>499ms within last 90 days.
- Current pregnancy or lactation.
- Inability to take oral medications.
- Positive CAGE and/or Opioid Risk Tool - Revised questionnaire
- Known allergy or hypersensitivity to opioids, duloxetine, or any ingredient in their formulation.
- Concomitant use of excluded medications: methadone, other antidepressants (including within 14 days of discontinuing monoamine oxidase inhibitors), thioridazine, potent CYP1A2 inhibitors (such as fluvoxamine and some...
- Uncontrolled narrow-angle glaucoma.
- If women of child-bearing potential (i.e. Menstruation within \<2 years) are unable or unwilling to use Health Canada approved highly effective methods of contraception (hormonal contraceptives, intrauterine device or...
The study team makes the final eligibility decision.
Where it's taking place
- Nanaimo, British Columbia, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Victoria, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanaimo, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.