Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Sublingual Methadone

About this trial

This is an interventional treatment trial for Cancer focused on measuring Sublingual Methadone, Cancer related breakthrough pain, feasibility study, Phase II/open label, Outpatients, Safety/ efficacy, previously receiving opioids, speak English

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pain due to cancer or its treatment; controlled baseline pain; episodes of breakthrough pain every day that are "4/10" in severity or greater, ; ast 10 minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent; are able to fill out the study forms Exclusion Criteria: Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid; prior sensitivity to methadone; currently are being administered methadone; have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain, new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain); are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Sites / Locations

Tom Baker Cancer Center
Tom Baker Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacokinetic

Arm Description

One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of >90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards

Outcomes

Primary Outcome Measures

to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting

Secondary Outcome Measures

to develop a model of PK/PD study of breakthrough pain

to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)

to demonstrate proof of concept

Full Information

NCT ID

NCT00351715

First Posted

July 11, 2006

Last Updated

October 17, 2019

Sponsor

AHS Cancer Control Alberta

Collaborators

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT00351715

Brief Title

Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

Official Title

Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Terminated

Why Stopped

Study stopped due to low accrual

Study Start Date

July 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

University of Calgary

4. Oversight

5. Study Description

Brief Summary

The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population 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 optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pain

Keywords

Sublingual Methadone, Cancer related breakthrough pain, feasibility study, Phase II/open label, Outpatients, Safety/ efficacy, previously receiving opioids, speak English

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pharmacokinetic

Arm Type

Experimental

Arm Description

One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of >90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards

Intervention Type

Drug

Intervention Name(s)

Sublingual Methadone

Primary Outcome Measure Information:

Title

to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting

Time Frame

12 months

Secondary Outcome Measure Information:

Title

to develop a model of PK/PD study of breakthrough pain

Time Frame

Baseline to 5 years

Title

to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)

Time Frame

Baseline to 5 years

Title

to demonstrate proof of concept

Time Frame

Baseline to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Pain due to cancer or its treatment; controlled baseline pain; episodes of breakthrough pain every day that are "4/10" in severity or greater, ; ast 10 minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent; are able to fill out the study forms Exclusion Criteria: Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid; prior sensitivity to methadone; currently are being administered methadone; have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain, new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain); are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Hagen, MD

Organizational Affiliation

AHS Cancer Control Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Center

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

Country

Canada

Cancer, Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial