NCT02856399

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

3.8 years

First QC Date

August 2, 2016

Last Update Submit

August 3, 2016

Conditions

Cancer Pain

Keywords

methadonecancer painlong term effect

Outcome Measures

Primary Outcomes (1)

  • Difference between EVA pain score at Day 28 and Day 0

    long-term effects of methadone for cancer pain

    pain score measure at Day 0 and Day 28

Secondary Outcomes (4)

  • Change in score of neuropathic pain intensity NPSI

    Day 0 and Day 28

  • Change in depression and anxiety score HADS

    Day 0 and Day 28

  • Change in quality of life score QOL C30

    Day 0 and Day 28

  • Side effect record

    up to Day 28

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a methadone treatment for cancer pain

You may qualify if:

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

You may not qualify if:

  • Patients PS 3
  • Unable to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marilene FILBET, Pr Associate

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilene FILBET, Pr Associate

CONTACT

(0)478864148marilene.filbet@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

November 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

FR(1)