Status:
WITHDRAWN
Methadone for 'Adenocarcinopathic' Pain Treatment
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Bruyère Health Research Institute.
The Ottawa Hospital
Conditions:
Cancer Pain
Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Methadone is an opioid that has been used for over 80 years to treat various types of pain, including cancer pain. Despite its increasing popularity as a co-analgesic and first-line treatment for canc...
Detailed Description
Background: Methadone is an opioid that has been used for over 80 years to treat various types of pain, including cancer pain. Its use as a co-analgesic and first-line treatment for cancer pain is be...
Eligibility Criteria
Inclusion
- Cancer type is adenocarcinoma;
- In the physician's opinion, mechanism of pain is most likely linked to an adenocarcinoma 'in proximity to' or invading a nerve or nerve plexus (i.e., 'adenocarcinopathic' pain; ACPP);
- Experiencing poorly controlled pain (defined as pain of 4 or higher on a 10-point visual analogue scale) despite the use of non-opioid analgesics or despite the regular use of up to 60 mg morphine equivalent daily dose (MEDD);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2;
- Estimated prognosis of at least 3 months;
- Able to fill out questionnaires and understand procedures in English and/or French;
- Able to provide first person informed consent;
- Physician deems it appropriate to start the patient on the opioid.
Exclusion
- Known QTc prolongation (QTc greater than 500ms, QRS less than 120ms) or known congenital QTc prolongation syndrome;
- Taking at least one medication that increases risk of Torsades de Pointes (TdP): cisapride, disopyramide, dofetilide, flecainide, procainamide, propafenone, quinidine, quinine, sotalol;
- History of opioid abuse or dependence using Edmonton Pain Classification;
- Has geographic difficulties with follow-up in person;
- Has any of the following comorbidities: documented class 3 or 4 New York Heart Association (NYHA) heart failure, myocardial infarction in the last 3 months, unstable angina, pericardial disease, oxygen dependent pulmonary diseases, Parkinson's disease, suspected or diagnosed dementia, bipolar disorder, poorly managed major depression (current or treated) or anxiety disorder;
- Taking medication known to have clinically significant interactions with the CYP450 enzyme: carbamazepine, efavirenz, phenobarbital, rifampicin, azole antifungals, antiretrovirals, grapefruit juice, clarithromycin, erythromycin;
- Diagnosed with Child-Pugh class B and/or C cirrhosis;
- Has hepatic insufficiency, defined as jaundice with irreversible hyperbilirubinemia of at least 34 micromol/L despite biliary tract stents (severity criteria in Child-Pugh-Turcotte score);
- Received radiation or any nerve block or plexus block on the same side as the pain in the past 14 days or PLANNED within the next 14 days;
- PLANNED prescription for daily co-analgesia with pregabalin, gabapentin, or dexamethasone during the next 14 days (not including dexamethasone with chemotherapy);
- Taking medication associated with major risk of serotonin syndrome (monoamine oxidase inhibitors; MAOIs): linezolid, moclobemide, rasagiline, selegiline;
- Taking medication known to be an opioid agonist, antagonist, or partial agonist: naltrexone, buprenorphine, tapentadol, tramadol;
- Other negative characteristic as per physician discretion (e.g., reduced renal function).
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05325164
Start Date
September 1 2022
End Date
September 1 2023
Last Update
December 5 2022
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