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

NCT02687347 | Unknown Phase 3 DMC

• 1 other identifier: 15-369 MP-CUSM
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• pain relief

  1\) Pain item of the Edmonton Symptom Assessment Scale

  2 months

• pain relief

  Questions 3 to 6 of the Brief Pain Inventory

  2 months

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

  2 months

Other Outcomes (1)

• pain interference

  2 months

Study Arms (2)

study arm

EXPERIMENTAL

low dose methadone (1-10mg daily)

Drug: oral methadone

control arm

ACTIVE COMPARATOR

low dose morphine (1-10 mg/day)

Drug: oral morphine

Interventions

oral methadone DRUG

Oral methadone is the study drug

study arm

oral morphine DRUG

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

control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Alan Edwards Pain Management Unit. Mcgill University Health Centre

Montreal, Quebec, H3G1A4, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Intractable

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)