Genetic, Neurophysiological and Psychological Predictive Factors of Chronic Neuropathic Pain After Surgery for Breast Cancer (DOLORISKSEIN)

Hopital Foch

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Other: Neurophysiological and psychophysical evaluations; Other: Quality of life questionnaires; Other: Chronic pain identification questionnaires; Genetic: Genetical analyses

Study type: Interventional

Funder types: Other

Identifiers

NCT02944721

2016-A00225-46 (Other Identifier)

2016/07

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Transversal study

Other group

Description:

Patients who had surgery for breast cancer for 2 years or less

Treatment:

Other: Quality of life questionnaires

Other: Neurophysiological and psychophysical evaluations

Genetic: Genetical analyses

Other: Chronic pain identification questionnaires

Longitudinal study

Other group

Description:

Patients that must be operated for a breast cancer

Treatment:

Other: Quality of life questionnaires

Other: Neurophysiological and psychophysical evaluations

Genetic: Genetical analyses

Other: Chronic pain identification questionnaires