Long-term Effects of Methadone for Cancer Pain

August 3, 2016 updated by: Hospices Civils de Lyon

The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.

The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing a methadone treatment for cancer pain

Description

Inclusion Criteria:

  • Patients with t methadone for cancer pain in opioid rotation
  • Able to fill the questionnaire
  • Performance status (PS) from 0 to 2

Exclusion Criteria:

  • Patients PS 3
  • Unable to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between EVA pain score at Day 28 and Day 0
Time Frame: pain score measure at Day 0 and Day 28
long-term effects of methadone for cancer pain
pain score measure at Day 0 and Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in score of neuropathic pain intensity NPSI
Time Frame: Day 0 and Day 28
Day 0 and Day 28
Change in depression and anxiety score HADS
Time Frame: Day 0 and Day 28
Day 0 and Day 28
Change in quality of life score QOL C30
Time Frame: Day 0 and Day 28
Day 0 and Day 28
Side effect record
Time Frame: up to Day 28
up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Marilene FILBET, Pr Associate, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0523

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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