Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Edema

Breast Diseases

Skin Diseases

All the patients will wear MOBIDERM Intimate bra composed of a bra and a MOBIDERM pad

At the conclusion of the surgical operation, MOBIDERM Intimate bra will be placed on the patient by the medical team. It will be recommended for the patients to wear MOBIDERM Intimate Bra during day and night for 3 weeks after the surgery, and as much time as the patients tolerate the device during the rest of the study, until 6 months after radiotherapy

Mobiderm Intimate Bra group

Stéphanie VILLET, Dr

Alyssia MARQUES

Séverine ALRAN, Dr

The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.

Breast cancer is the most common malignancy in women in the Western World. BCS followed by radiotherapy is a safe and effective procedure to treat patients with early-stage \[Verbelen H., 2021\]. But some patients are troubled by breast edema in the operated and irradiated breast. The consequences of breast edema can be : an increase in breast volume, orange peel skin, heaviness of the breast, redness of the skin, breast pain, thickening of the skin, hyperpigmented skin pores \[Verbelen H., 2014\]. Breast edema can also imply deterioration in patients' quality of life, physical functioning, and body image \[Young-Afat D. A., 2019\].

According to the literature, only a few clinical studies evaluated the value of compression medical devices in the management of breast edema.

The aim of the study is to perform a prospective, exploratory, monocentric, uncontrolled clinical study to look at the performance and safety of Mobiderm Intimate Bra in the management of breast edema related to breast cancer treatment.

Prospective, exploratory, monocentric, uncontrolled clinical study.

Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

Evaluation of the Performance and Safety of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment - A Prospective, Exploratory, Monocentric, Uncontrolled Clinical Study

The evolution of breast edema severity will be assessed all along the study follow-up using the patient-completed "Symptoms" section of the Breast Edema Questionnaire (BrEQ): 8 questions about symptoms of breast edema scored on a scale from 0 to 10 (0 = no difficulty and 10: maximal difficulty). The maximum score is 80 .

Measurement of the Tissue Dielectric Constant (TDC) of the breast tissue will be done using the MoistureMeter D (Delfin Technologies Ltd, Finland).

Clinical assessment will be done by observation and palpation of the breast by the medical team to monitor changes in the severity of breast edema.

High-frequency cutaneous ultrasound measurements will be done by the medical team to monitor changes in the severity of breast edema (echogenicity, skin thickness).

The time between surgery and/or radiotherapy and the diagnosis of breast edema will be assessed by analysing the responses to the "Symptoms" section of the BrEQ questionnaire completed weekly.

The time to disappearance of the breast edema will be assessed by analysing the responses to the "Symptoms" section of the BrEQ questionnaire completed weekly.

Changes in symptoms (pain, heaviness, swelling, tension, hardness and redness of the skin, etc.) and quality of life related to breast edema will be assessed by the patient by filling in the BrEQ self-questionnaire. The 8 questions related to symptoms and 16 questions related to quality of life are scored on a scale from 0 to 10 (0 = no difficulty and 10: maximal difficulty). The maximum score is 80 for the symptoms part and 160 for the Quality of life part.

The evolution of breast hypersensitivity will be assessed using a Visual Analogue Scale (VAS) (score from 0 to 10 with 0 = no hypersensibility and 10 = maximum hypersensibility).

The presence of breast pain will be assessed using a VAS (score from 0 to 10 with 0 = no pain and 10 = Maximal pain).

Changes in skin fibrosis/hardness will be assessed using the SkinFibroMeter (Delfin Technologies Ltd, Finland).

The time taken to resume physical activity will be measured by means of a specific question to the patient.

The healing time will be calculated following observation of scar oozing by the medical team.

The safety of the device will be assessed by describing the adverse events (AEs) and serious adverse events (SAEs) that occur throughout the study.

The Investigator will report compliance with the device at each visit using the patient's diary, which the patient shall complete throughout the follow-up period

Patient's satisfaction with the MOBIDERM Intimate Bra device will be evaluated with a specific self-questionnaire given to the patient.

Spots Global Cancer Trial Database for mobiderm intimate bra group