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

NCT06303154 | Active Not Recruiting

• 2 other identifiers: EC45 MOBIBRAID-RCB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Surgery

Keywords

Breast cancer; Surgery; Compressive bra; Breast edema

Outcome Measures

Primary Outcomes (1)

• Evolution of breast edema severity

  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 .

  Between 35 and 44 weeks (6 months after radiotherapy)

Secondary Outcomes (14)

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

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

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

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

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

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

• Time to edema onset

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

• Time to edema disappearance

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

Study Arms (1)

Mobiderm Intimate Bra group

EXPERIMENTAL

All the patients will wear MOBIDERM Intimate bra composed of a bra and a MOBIDERM pad

Device: Mobiderm Intimate Bra group

Interventions

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

Mobiderm Intimate Bra group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP

Paris, Paris 14, 75014, France

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  PMID: 31360894 BACKGROUND

• 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.

  PMID: 25164973 BACKGROUND

• 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.

  PMID: 33775252 BACKGROUND

• 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.

  PMID: 31233373 BACKGROUND

• 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.

  PMID: 31211631 BACKGROUND

• 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.

  PMID: 31659592 BACKGROUND

• 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.

  PMID: 33761280 BACKGROUND

• 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.

  PMID: 34455642 BACKGROUND

• 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.

  PMID: 31596657 BACKGROUND

• 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.

  PMID: 18077074 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Séverine ALRAN, Dr

  Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, exploratory, monocentric, uncontrolled clinical study.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)