Etude : CAPTRANE /

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : CAPTRANE

Situation thérapeutique :

Traitement : Chirurgie

Cadre réglementaire : RIPH1

Dernière MÀJ : 20/05/2022
CIM10 - Localisation(s)
Informations principales
Titre : Etude multicentrique, ouverte, randomisée, comparant le traitement topique par patch de capsaïcine à 8% (Qutenza) à la Prégabaline per os dans le traitement précoce des névralgies inter costo brachiales après une chirurgie primaire pour cancer du sein

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Informations complémentaires
Schéma : 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 to the disease itself or to the therapies used.
As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.
Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.
Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.
Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.
In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.
Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.
The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.
Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.
However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.
We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.

Phase : III

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'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

Critères de non-inclusion : - 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
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
44000 NANTES

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier de Valenciennes - Avenue Désandrouin - CS 50479 - 59300 VALENCIENNES

Investigateur :
Docteur Antoine LEMAIRE

Madame Marielle FERY
03 27 14 07 15

Statut de l'essai : CLOS

MAJ : 02/05/2022

Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Abesse AHMEIDI

Unité Intégrée de Recherche Clinique

Statut de l'essai : CLOS

MAJ : 20/05/2022