Clinical trial · Interventional
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to 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
NCT06303154CI-TRIAL-00094832MOBIBRAactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobiderm Intimate Bra group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mobiderm Intimate Bra group
- description
- All the patients will wear MOBIDERM Intimate bra composed of a bra and a MOBIDERM pad
- interventionNames
- Device: Mobiderm Intimate Bra group
Primary outcomes (1)
- measure
- Evolution of breast edema severity
- timeFrame
- Between 35 and 44 weeks (6 months after radiotherapy)
- description
- 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 .
Secondary outcomes (14)
- measure
- Comparison of methods to follow changes in the severity of breast edema - TDC measurement
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDJohansson 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.
- BACKGROUNDYoung-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
- BACKGROUNDVerbelen 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
- BACKGROUNDVerbelen 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
- BACKGROUNDJohansson 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
- BACKGROUNDGregorowitsch 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
- BACKGROUNDVerbelen 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.