Using Mobiderm Intimate Bra to Manage Breast Edema After 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
NA · Thuasne · NCT06303154
This study tests if wearing the Mobiderm Intimate Bra can help women with breast cancer manage swelling after surgery and radiation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thuasne (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Paris, Paris 14) |
| Trial ID | NCT06303154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and older who have undergone conserving surgery for breast cancer and are about to start radiation therapy.
Not a fit: Patients with an A cup bra size or those requiring chemotherapy during the follow-up period may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients experiencing breast edema after cancer treatment.
How similar studies have performed: Few clinical studies have evaluated the use of compression devices for breast edema, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris, Paris 14
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Surgery, Breast cancer, Surgery, Compressive bra, Breast edema