Breast Cancer Patient
Conditions
Keywords
Breast cancer patient, Surgery, Inter Costobrachial Neuralgia
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.
Interventions
DRUGCapsaicin
Application of capsaicin patches at 8% on painful area
DRUGPregabalin
Taking Pregabalin tablets
Sponsors
Institut Cancerologie de l'Ouest
Grünenthal GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Multicenter, open, randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10) | 2 months | Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where: * 0 indicates no pain, * 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10) | 6 months | Neuropathic pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure represents the change in NRS score from baseline to 6 months, calculated as the score at 6 months minus the score at baseline. Negative values indicate an improvement in pain, and positive values indicate worsening of pain. |
Countries
France
Contacts
STUDY_DIRECTORDENIS DUPOIRON, MD
Institut de Cancérologie de l'Ouest
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Race/Ethnicity, Customized Not Reported | 65 Participants |
| Region of Enrollment France | 51 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 51 |
| other Total, other adverse events | 8 / 65 | 29 / 51 |
| serious Total, serious adverse events | 0 / 65 | 0 / 51 |
Outcome results
None listed