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Trial Title:
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
NCT ID:
NCT06303154
Condition:
Breast Cancer Surgery
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Surgery
Compressive bra
Breast edema
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective, exploratory, monocentric, uncontrolled clinical study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Mobiderm Intimate Bra group
Description:
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
Arm group label:
Mobiderm Intimate Bra group
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
Séverine ALRAN, Dr
Start date:
March 21, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Thuasne
Agency class:
Industry
Source:
Thuasne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06303154
