Clinical trial NCT03794388: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Patient
Keywords: Breast cancer patient
Surgery
Inter Costobrachial Neuralgia
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Grünenthal GmbH
First posted: 2019-01-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, open, randomized study
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: To show the noninferiority of early early medical treatment by topical treatment with capsaicin compared to oral treatment of pregabalin on the evolution of neuropathic pain after 2 months in patients who have undergone surgical excision of breast cancer
timeFrame: 2 months
Secondary outcomes:
measure: To compare the efficacy of an early medical treatment with capsaicin topical treatment compared to oral treatment pregabalin on the evolution of neuropathic pain in patients who had undergone excision surgical breast cancer after 6 months of treatment
timeFrame: 6 months
measure: To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms: Questionnaire PGIC (patients' global impression of change)
timeFrame: 6 months
measure: To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms
timeFrame: 6 months
measure: To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms
timeFrame: 6 months
measure: Regression of the painful area after 2 and 6 months of treatment between the two arms.
timeFrame: 6 months
measure: Tolerance of each type of treatment by collecting side effects in each treatment arm.
timeFrame: 6 months
measure: Proportion of patients for whom only 1 application has been sufficient.
timeFrame: 6 months
measure: Impact of peri-surgical anxiety and depression on the development of neuropathic pain after surgery for breast cancer
timeFrame: 49 months
measure: The incidence of NICBs 4 months after surgery for breast cancer
timeFrame: 4 months
measure: The evolution of the weight between the two arms after 6 months of treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: Grenoble
country: France
facility: Chu Grenoble
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hopital Saint Vincent de Paul
city: Lyon
country: France
facility: Centre Leon Berard
city: Nice
country: France
facility: CHU NICE
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-Cloud
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: Iuct Oncopole
city: Valenciennes
country: France
facility: Ch Valenciennes
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: DENIS DUPOIRON, MD
role: STUDY_DIRECTOR
References: