Genetic, Neurophysiological and Psychological Risk Factors for Neuropathic Pain

Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer

The objective of these cohorts is to detect potential genetic, neurophysiological psychological and cognitive risk factors for the development of chronic postsurgical pain including neuropathic pain.

Study Overview

• Status: Completed
• Conditions: Surgery

Detailed Description

This new study will enroll patients undergoing mastectomy or thoracotomy for cancer. They will be three cohorts :

• one prospective cohort constituted of women undergoing breast surgery in René Huguenin Hospital (Saint Cloud) and followed for up to one year after surgery.
• another cross sectional cohort constituted of patient association (Seintinelle) including women operated up to 2 years previously from breast surgery.
• One prospective cohort constituted of women or men undergoing thoracotomy in Foch hospital (Suresnes) and followed for up to one year after surgery.

The main objectives of these cohorts will be to detect potential genetic, neurophysiological, psychological and cognitive risk factors for the development of chronic postsurgical neuropathic pain.

These patients will questioned about demographics, age, sex, body mass index. A large neuropsychological and psychological battery of tests will be conducted. Sensory function will assessed using quantitative sensory testing. Biological samples will analyse potential genetic factors in the development of neuropathic pain after surgery. Conditioned pain modulation, threshold tracking and quantitative sensory testing will also be assessed in subgroup of patients.

The prospective cohort will be assessed before surgery then 3, 6 and 12 months after surgery. The cross sectional cohort will be assessed during one to two visits in hospital.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Boulogne Billancourt, France, 92100
    • Hopital Ambroise Pare
  • Hauts De Seine
    • Suresnes, Hauts De Seine, France, 92
      • Hôpital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The first group of patients consists of women recruited from René Huguenin Hospital (Saint Cloud, Ile de France) for mastectomy or lumpectomy to treat breast cancer, with axillary lymph node dissection in all cases.

The second cohort will consist of women already operared of breast surgery in the last 2 years.

The third cohort will consist of men or women recruited from Foch hospital (Suresnes, Ile de France) for thoracotomy for cancer.

Description

Inclusion Criteria:

• Patients undergoing surgery for breast cancer or thoracotomy for lung cancer followed during the course of the study or patients from the French cohort Seintinelle already operated from breast surgery over the past 2 years.

Exclusion criteria :

• Patients are not included if they have clinically significant or unstable psychiatric or somatic conditions (e.g. major depression, psychosis, uncontrolled diabetes mellitus or hypertension, neurological disorders, immune disease, body mass index > 45), past or present substance abuse or any cognitive deterioration based on past medical history, semi-structured interview and lack of completion or full understanding of questionnaires.
• Bilateral mastectomy (for women undergoing breast surgery)
• Presence of pain before surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
prospective cohort of patients undergoing mastectomy; Prospective cohort
cross sectional cohort of patients; Cross sectional cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuropathic pain	neuropathic pain assessed with the DN4 questionnaire	3, 6 and 12 months after surgery in the prospective cohort

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic postsurgical pain	chronic pain questionnaire identification	3, 6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Hospital Ambroise Paré Paris
• Collaborators: Hopital Foch
• Investigators: Principal Investigator: Nadine ATTAL, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: Predictive cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED