Status:
COMPLETED
Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Breast Cancer Patient
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related...
Eligibility Criteria
Inclusion
- Male or female who had first breast cancer surgery, regardless of the type of surgery
- Age ≥ 18 years
- Healthy, non-irritated skin on painful areas to treat
- During the inclusion visit to M4 post surgery, neuropathic pain of the breast and / or axillary area corresponding to inter-brachial neuralgia with a DN4≥4 score.
- Obtaining the signed written consent of the patient
- Major patient affiliated to a social security scheme
Exclusion
- Contraindications specific to the treatments studied : capsaicine and pregabalin
- Diabetic patient
- Previous treatment with capsaicin or pregabalin
- Opioid treatment\> 80 mg / day (oral morphine equivalent) in progress- Topical treatment of pain between surgery and inclusion visit
- Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (\<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
- Creatinine clearance (CLcr) \<60mL / min according to the Cockcroft-Gault formula
- Pregnant woman, likely to be pregnant or breastfeeding
- Persons deprived of their liberty or guardianship (including curators),
- Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03794388
Start Date
March 19 2019
End Date
November 18 2022
Last Update
August 1 2023
Active Locations (11)
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1
Institut de Cancerologie de L'Ouest
Angers, France, 49000
2
Chu Grenoble
Grenoble, France, 38700
3
Chd Vendee
La Roche-sur-Yon, France, 85025
4
Centre Oscar Lambret
Lille, France, 59020