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

Breast Cancer Surgery Clinical Trial

— MOBIBRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303154
• Other study ID #: EC45 MOBIBRA
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Thuasne
• Contact: Stéphanie VILLET, Dr
• Phone: +33 6 47 78 04 29
• Email: stephanie.villet[@]thuasne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Surgery
• Breast Neoplasms

Intervention

Device:
• Mobiderm Intimate Bra group
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

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP	Paris	Paris 14

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of methods to follow changes in the severity of breast edema - TDC measurement	Measurement of the Tissue Dielectric Constant (TDC) of the breast tissue will be done using the MoistureMeter D (Delfin Technologies Ltd, Finland).	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Comparison of methods to follow changes in the severity of breast edema - Clinical assessment	Clinical assessment will be done by observation and palpation of the breast by the medical team to monitor changes in the severity of breast edema.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement	High-frequency cutaneous ultrasound measurements will be done by the medical team to monitor changes in the severity of breast edema (echogenicity, skin thickness).	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Time to edema onset	The time between surgery and/or radiotherapy and the diagnosis of breast edema will be assessed by analysing the responses to the "Symptoms" section of the BrEQ questionnaire completed weekly.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Time to edema disappearance	The time to disappearance of the breast edema will be assessed by analysing the responses to the "Symptoms" section of the BrEQ questionnaire completed weekly.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Symptoms and quality of life changes associated with breast edema	Changes in symptoms (pain, heaviness, swelling, tension, hardness and redness of the skin, etc.) and quality of life related to breast edema will be assessed by the patient by filling in the BrEQ self-questionnaire. The 8 questions related to symptoms and 16 questions related to quality of life are scored on a scale from 0 to 10 (0 = no difficulty and 10: maximal difficulty). The maximum score is 80 for the symptoms part and 160 for the Quality of life part.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Breast edema hypersensitivity	The evolution of breast hypersensitivity will be assessed using a Visual Analogue Scale (VAS) (score from 0 to 10 with 0 = no hypersensibility and 10 = maximum hypersensibility).	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Breast pain	The presence of breast pain will be assessed using a VAS (score from 0 to 10 with 0 = no pain and 10 = Maximal pain).	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Skin changes associated with breast edema	Changes in skin fibrosis/hardness will be assessed using the SkinFibroMeter (Delfin Technologies Ltd, Finland).	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Physical activity	The time taken to resume physical activity will be measured by means of a specific question to the patient.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Healing time	The healing time will be calculated following observation of scar oozing by the medical team.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Safety of the device	The safety of the device will be assessed by describing the adverse events (AEs) and serious adverse events (SAEs) that occur throughout the study.	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Compliance to the device	The Investigator will report compliance with the device at each visit using the patient's diary, which the patient shall complete throughout the follow-up period	Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Secondary	Patient's satisfaction	Patient's satisfaction with the MOBIDERM Intimate Bra device will be evaluated with a specific self-questionnaire given to the patient.	3 weeks after surgery and 6 months after radiotherapy (end of study)