Using Mobiderm Intimate Bra to Manage Breast Edema After Breast Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory study aims to evaluate the effectiveness and tolerability of the Mobiderm Intimate Bra in managing breast edema that can occur after breast cancer surgery and radiation therapy. The study will be conducted at a single center and will involve female patients who have undergone conserving surgery for breast cancer and are scheduled for radiation treatment. Participants will wear the bra to assess its performance in alleviating symptoms associated with breast edema, such as increased breast volume and skin changes. The study will also monitor the safety of the device throughout the intervention period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
  Paris, Paris 14, France Recruiting

Study contacts

• Principal investigator: Séverine ALRAN, Dr — Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
• Study coordinator: Stéphanie VILLET, Dr
• Email: stephanie.villet@thuasne.fr
• Phone: +33 6 47 78 04 29

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.