Long-term Effects of Methadone for Cancer Pain

Cancer Pain Clinical Trial

Official title:

Long-term Effects of Methadone for Cancer Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856399
• Other study ID #: 69HCL16_0523
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 3, 2016
• Start date: November 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: Marilene FILBET, Pr Associate
• Phone: (0)478864148
• Email: marilene.filbet[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer Pain

Locations

Country	Name	City	State
France	Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in score of neuropathic pain intensity NPSI		Day 0 and Day 28	No
Secondary	Change in depression and anxiety score HADS		Day 0 and Day 28	No
Secondary	Change in quality of life score QOL C30		Day 0 and Day 28	No
Secondary	Side effect record		up to Day 28	No