Clinical trial NCT06303154: Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Surgery
Keywords: Breast cancer
Surgery
Compressive bra
Breast edema
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, exploratory, monocentric, uncontrolled clinical study.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Evolution of breast edema severity
timeFrame: Between 35 and 44 weeks (6 months after radiotherapy)
Secondary outcomes:
measure: Comparison of methods to follow changes in the severity of breast edema - TDC measurement
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Comparison of methods to follow changes in the severity of breast edema - Clinical assessment
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Time to edema onset
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Time to edema disappearance
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Symptoms and quality of life changes associated with breast edema
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Breast edema hypersensitivity
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Breast pain
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Skin changes associated with breast edema
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Physical activity
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Healing time
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Safety of the device
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Compliance to the device
timeFrame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
measure: Patient's satisfaction
timeFrame: 3 weeks after surgery and 6 months after radiotherapy (end of study)
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
state: Paris 14
Study officials:
affiliation: Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
name: Séverine ALRAN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johansson K. et al. Two-year follow-up of temporal changes of breast edema after breast cancer treatment with surgery and radiation evaluated by tissue dielectric constant (TDC). The European Journal of Lymphology and related problem. 2015; 27:73.
citation: Young-Afat DA, Gregorowitsch ML, van den Bongard DH, Burgmans I, van der Pol CC, Witkamp AJ, Bijlsma RM, Koelemij R, Schoenmaeckers EJ, Jonasse Y, van Gils CH, Verkooijen HM. Breast Edema Following Breast-Conserving Surgery and Radiotherapy: Patient-Reported Prevalence, Determinants, and Effect on Health-Related Quality of Life. JNCI Cancer Spectr. 2019 Apr 16;3(2):pkz011. doi: 10.1093/jncics/pkz011. eCollection 2019 Jun.
citation: Verbelen H, Gebruers N, Beyers T, De Monie AC, Tjalma W. Breast edema in breast cancer patients following breast-conserving surgery and radiotherapy: a systematic review. Breast Cancer Res Treat. 2014 Oct;147(3):463-71. doi: 10.1007/s10549-014-3110-8. Epub 2014 Aug 28.
citation: Verbelen H, Tjalma W, Dombrecht D, Gebruers N. Breast edema, from diagnosis to treatment: state of the art. Arch Physiother. 2021 Mar 29;11(1):8. doi: 10.1186/s40945-021-00103-4.
citation: Johansson K, Jonsson C, Bjork-Eriksson T. Compression Treatment of Breast Edema: A Randomized Controlled Pilot Study. Lymphat Res Biol. 2020 Apr;18(2):129-135. doi: 10.1089/lrb.2018.0064. Epub 2019 Jun 24.
citation: Gregorowitsch ML, Van den Bongard DHJG, Batenburg MCT, Traa-van de Grootevheen MJC, Fuhler N, van Het Westeinde T, van der Pol CC, Young-Afat DA, Verkooijen HM. Compression Vest Treatment for Symptomatic Breast Edema in Women Treated for Breast Cancer: A Pilot Study. Lymphat Res Biol. 2020 Feb;18(1):56-63. doi: 10.1089/lrb.2018.0067. Epub 2019 Jun 18.
citation: Verbelen H, De Vrieze T, Van Soom T, Meirte J, Van Goethem M, Hufkens G, Tjalma W, Gebruers N. Development and clinimetric properties of the Dutch Breast Edema Questionnaire (BrEQ-Dutch version) to diagnose the presence of breast edema in breast cancer patients. Qual Life Res. 2020 Feb;29(2):569-578. doi: 10.1007/s11136-019-02337-z. Epub 2019 Oct 28.
citation: Mayrovitz HN, Somarriba C, Weingrad DN. Breast Tissue Dielectric Constant as a Potential Breast Edema Assessment Parameter. Lymphat Res Biol. 2022 Feb;20(1):33-38. doi: 10.1089/lrb.2020.0137. Epub 2021 Mar 24.
citation: Kilbreath SL, Fearn NR, Dylke ES. Ultrasound: Assessment of breast dermal thickness: Reliability, responsiveness to change, and relationship to patient-reported outcomes. Skin Res Technol. 2022 Jan;28(1):111-118. doi: 10.1111/srt.13100. Epub 2021 Aug 29.
citation: Yu Z, Liu N, Wang L, Chen J, Han L, Sun D. Assessment of Skin Properties in Chronic Lymphedema: Measurement of Skin Stiffness, Percentage Water Content, and Transepidermal Water Loss. Lymphat Res Biol. 2020 Jun;18(3):212-218. doi: 10.1089/lrb.2018.0066. Epub 2019 Oct 9.
citation: Delay E, Gosset J, Toussoun G, Delaporte T, Delbaere M. [Post-treatment sequelae after breast cancer conservative surgery]. Ann Chir Plast Esthet. 2008 Apr;53(2):135-52. doi: 10.1016/j.anplas.2007.10.004. Epub 2008 Feb 20. French.