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 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.

Inclusion Criteria:

• Females aged 18 years and older.
• Patients who have undergone conserving surgery for breast cancer.
• Patients scheduled to undergo radiation treatment of the breast/chest wall within the next 12 weeks after surgery.
• Patients with a morphology compatible with the proposed sizes of the devices, including bust girth and cup size.
• Patients who have signed an informed consent form prior to any study intervention.
• Patients with full legal capacity and enrolled in a social security system or covered by a similar health insurance.

Exclusion Criteria:

• Patients with an A cup bra size.
• Patients with infected or acutely inflammatory skin on the chest.
• Patients who require chemotherapy during the follow-up period.
• Pregnant women or women of childbearing age without adequate contraception or in the lactation period.
• Participation in other clinical trials that impact the primary endpoint.
• Patients with a known allergy to the investigational device components.
• Patients with psychiatric, psychological, or neurological disorders that are incompatible with the conduct of a clinical trial.
• Patients unable to be followed for 12 months.
• Vulnerable patients, or those subject to a judicial protection measure or unable to provide informed consent freely.