Long-term Effects of Methadone for Cancer Pain | NCT02856399

Studies
Long-term Effects of Methadone for Cancer Pain

NCT02856399

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Aug 4, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Cancer Pain

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Aug 2018Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 3, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing a methadone treatment for cancer pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marilene FILBET, Pr Associate	Contact	(0)478864148	+33	marilene.filbet@chu-lyon.fr

Overall Officials

Name	Affiliation	Role
Marilene FILBET, Pr Associate	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet	Recruiting	Pierre-Bénite		69310	France

Condition Browse Module

MeSH Terms

ID	Term
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided