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

N/AActive Not RecruitingNCT06303154

Thuasne30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Surgery

Interventions

Mobiderm Intimate Bra groupDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP

Paris, Paris 14, France

Outcomes

Primary Outcomes

Evolution of breast edema severity

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 .

Time frame: Between 35 and 44 weeks (6 months after radiotherapy)

Secondary Outcomes

Comparison of methods to follow changes in the severity of breast edema - TDC measurement

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

Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)

Comparison of methods to follow changes in the severity of breast edema - Clinical assessment

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.

Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)

Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement

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

Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)

Time to edema onset

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.

Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)

Data from ClinicalTrials.gov

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