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Spots Global Cancer Trial Database for Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

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Trial Identification

Brief Title: Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

Official Title: Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer

Study ID: NCT03794388

Interventions

Capsaicin
Pregabalin

Study Description

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 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut de Cancerologie de L'Ouest, Angers, , France

Chu Grenoble, Grenoble, , France

Chd Vendee, La Roche-sur-Yon, , France

Centre Oscar Lambret, Lille, , France

Hopital Saint Vincent de Paul, Lille, , France

Centre Leon Berard, Lyon, , France

CHU NICE, Nice, , France

Institut Jean Godinot, Reims, , France

Institut Curie, Saint-Cloud, , France

Iuct Oncopole, Toulouse, , France

Ch Valenciennes, Valenciennes, , France

Contact Details

Name: DENIS DUPOIRON, MD

Affiliation: Institut de Cancérologie de l'Ouest

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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