Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain

NCT ID: NCT02687347

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-12-31

Brief Summary

The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.

Conditions

Pain, Intractable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

study arm

low dose methadone (1-10mg daily)

Group Type: EXPERIMENTAL

oral methadone

Intervention Type: DRUG

Oral methadone is the study drug

control arm

low dose morphine (1-10 mg/day)

Group Type: ACTIVE_COMPARATOR

oral morphine

Intervention Type: DRUG

Oral morphine is the active comparator. It is not a placebo intervention

Interventions

oral methadone

Oral methadone is the study drug

Intervention Type: DRUG

oral morphine

Oral morphine is the active comparator. It is not a placebo intervention

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed of cancer-related pain of more than 3 months duration
• Pain relief during the last week rated unsatisfactory by the patient
• Pain severity during the last week rated moderate (between 4 and 7/10)
• Analgesic therapy must have been stable for 7 days
• Able to understand English or French
• Willing and able to give written informed consent

Exclusion Criteria

• Patients who are currently receiving or have received methadone as analgesic in the last 6 months
• Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)
• Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
• Patients whose life expectancy is shorter than 2 months
• Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
• Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Jordi Perez

Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alan Edwards Pain Management Unit. Mcgill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Jordi Perez, MD

Role: primary

jordi.perez@muhc.mcgill.ca

5149348222

Other Identifiers

15-369 MP-CUSM

Identifier Type: -

Identifier Source: org_study_id