Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
NCT ID: NCT02944721
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2016-11-30
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transversal study
Patients who had surgery for breast cancer for 2 years or less
Genetical analyses
Chronic pain identification questionnaires
Neurophysiological and psychophysical evaluations
Quality of life questionnaires
Longitudinal study
Patients that must be operated for a breast cancer
Genetical analyses
Chronic pain identification questionnaires
Neurophysiological and psychophysical evaluations
Quality of life questionnaires
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Genetical analyses
Chronic pain identification questionnaires
Neurophysiological and psychophysical evaluations
Quality of life questionnaires
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Having given a written consent form
* Affiliated to the social security scheme
* French language (read, written and spoken)
* Accepting the principle of the study and able to respect the conditions of the study.
* Patients who can be followed during the total duration of the study ( 12 months) for the longitudinal arm of the forward-looking study
* Patients that must be operated for one of the two types of surgery: preservative surgery or mastectomy for breast cancer with ganglionic cleaning out
* Chemotherapy or radiotherapy before the surgery
\- patients operated for a conservative surgery or a mastectomy for breast cancer with ganglionic cleaning out during 2 years before the inclusion
Exclusion Criteria
* Bilateral Mastectomy
* Presence of chronic pain before the intervention for breast cancer,
* occupational accident, dispute or search for compensation
* Previous surgery on the same territory
* Peripheral neurological pathology or central (brain damage, multiple sclerosis) susceptible to interfere with the evaluation of the post-operative pain
* Heavy psychiatric histories: psychosis, severe depression having motivated a hospitalization, a suicide attempt
* Current major depressive episode at the time of the evaluation (cf. criterion diagnosis of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5))
* Abuse of drug or psychoactive substance (cf. definition of the DSM-5) during the last six months; cognitive disorders (MMSE 24/30) or psychological incompatible with the respect and/or the understanding of the protocol
* Patients participating in another protocol of biomedical research.
For longitudinal study:
* Previous surgery for a breast cancer
* Patients that must be operated for a surgery of the breast without ganglionic cleaning out
For transversal study:
* patients operated for a surgery of the breast without ganglionic cleaning out
* Patients operated for more than 2 years
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hopital Foch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Didier BOUHASSIRA, MD
Role: PRINCIPAL_INVESTIGATOR
AP-HP Hopital A. Paré
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Ambroise Paré
Boulogne, , France
Centre René Huguenin
Saint-Cloud, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-A00225-46
Identifier Type: OTHER
Identifier Source: secondary_id
2016/07
Identifier Type: -
Identifier Source: org_study_id