Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients

Study Overview
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Brief Summary
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The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.

Official Title
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Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Sublingual Methadone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain due to cancer or its treatment; Controlled baseline pain; episodes of predictable, treatment related pain every day that are 4/10 in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients Exclusion Criteria: Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand English sufficiently to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sublingual Methadone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic, |  |  | 
| treatment related incident breakthrough pain. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to develop a research tool |  |  | 
| the Breakthrough Pain Assessment Tool (BPAT) |  |  | 
| and to demonstrated proof of concept |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sublingual methadone, iatrogenic, treatment related incident breakthrough pain, feasibility study, Phase II/open-label, inpatients, Safety/efficacy, Cancer related breakthrough pain, previously receiving opioids, speak English