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NCT Number: NCT06303154

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Surgery Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP

Paris, Paris 14, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobiderm Intimate Bra group

Device

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

Primary outcomes

  1. Evolution of breast edema severity

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

    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 .

Secondary outcomes

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

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

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

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

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

    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.

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

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

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

  4. Time to edema onset

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

    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.

  5. Time to edema disappearance

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

    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.

  6. Symptoms and quality of life changes associated with breast edema

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

    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.

  7. Breast edema hypersensitivity

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

    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).

  8. Breast pain

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

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

  9. Skin changes associated with breast edema

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

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

  10. Physical activity

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

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

  11. Healing time

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

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

  12. Safety of the device

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

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

  13. Compliance to the device

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

    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

  14. Patient's satisfaction

    Time frame: 3 weeks after surgery and 6 months after radiotherapy (end of study)

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

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Official study title

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

Acronym: MOBIBRA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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