Clinical trial NCT02944721: Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
Official title: Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Neuropathic Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to establish the genetic, neurophysiological and psychological phenotype of the patients presenting a persistent neuropathic pain after surgery of the breast cancer, by comparing the neuropathic painful patients with the not painful and with the not neuropathic painful . This will be realized on a transverse cohort ("Seintinelle"cohort) and confirmed on a forward-looking longitudinal cohort.


Eligibility criteria: For both arms:

Inclusion Criteria:

* Women over 18 years
* 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.

Exclusion Criteria:

* Other cancer or AIDS in evolution
* 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:

Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous surgery for a breast cancer
* Patients that must be operated for a surgery of the breast without ganglionic cleaning out

For transversal study:

Inclusion criteria:

- patients operated for a conservative surgery or a mastectomy for breast cancer with ganglionic cleaning out during 2 years before the inclusion

Exclusion criteria

* patients operated for a surgery of the breast without ganglionic cleaning out
* Patients operated for more than 2 years

Primary outcomes:
measure: Correlation coefficient between patients profile and type of pain
timeFrame: 13 months max
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne
country: France
facility: Hopital Ambroise Paré
city: Saint Cloud
country: France
facility: Centre René Huguenin
Study officials:
affiliation: AP-HP Hopital A. Paré
name: Didier BOUHASSIRA, MD
role: PRINCIPAL_INVESTIGATOR
References: