Breast Cancer SurgeryMOBIBRANCT06303154
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
A study testing Mobiderm Intimate Bra group in people with Breast Cancer Surgery, run by Thuasne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- Mobiderm Intimate Bra group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
Paris, Paris 14, 75014
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Surgery
- Being tested
- Mobiderm Intimate Bra group
- Keywords
- Breast cancer, Surgery, Compressive bra, Breast edema
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobiderm Intimate Bra groupDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Mobiderm Intimate Bra group | Experimental | All the patients will wear MOBIDERM Intimate bra composed of a bra and a MOBIDERM pad Receives: Device: Mobiderm Intimate Bra group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measurement of the Tissue Dielectric Constant (TDC) of the breast tissue will be done using the MoistureMeter D (Delfin Technologies Ltd, Finland).
Measured: 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
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.
Measured: 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
High-frequency cutaneous ultrasound measurements will be done by the medical team to monitor changes in the severity of breast edema (echogenicity, skin thickness).
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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).
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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).
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Skin changes associated with breast edema
Changes in skin fibrosis/hardness will be assessed using the SkinFibroMeter (Delfin Technologies Ltd, Finland).
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Physical activity
The time taken to resume physical activity will be measured by means of a specific question to the patient.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Healing time
The healing time will be calculated following observation of scar oozing by the medical team.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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.
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
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
Measured: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Patient's satisfaction
Patient's satisfaction with the MOBIDERM Intimate Bra device will be evaluated with a specific self-questionnaire given to the patient.
Measured: 3 weeks after surgery and 6 months after radiotherapy (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start21 Mar 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, exploratory, monocentric, uncontrolled clinical study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Séverine ALRAN, Dr, Principal investigator, Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303154
- Sponsor's protocol ID
- EC45 MOBIBRA
- Other IDs
- ID-RCB
- Acronym
- MOBIBRA
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 31360894Verbelen 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.
PubMed 25164973Verbelen 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.
PubMed 33775252Johansson 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.
PubMed 31233373Gregorowitsch 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.
PubMed 31211631Verbelen 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.
PubMed 31659592Mayrovitz 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.
PubMed 33761280Kilbreath 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.
PubMed 34455642Yu 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.
PubMed 31596657Delay 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.
PubMed 18077074
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06303154
- Acronym / sponsor ID
- MOBIBRA / EC45 MOBIBRA
- Conditions
- Breast Cancer Surgery
- Keywords
- Breast cancer, Surgery, Compressive bra, Breast edema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, exploratory, monocentric, uncontrolled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Mobiderm Intimate Bra group | Experimental | Device: Mobiderm Intimate Bra groupAll the patients will wear MOBIDERM Intimate bra composed of a bra and a MOBIDERM pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobiderm Intimate Bra groupAt 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 | Device | Mobiderm Intimate Bra group |
Primary outcome
Evolution of breast edema severity
Time frame: Between 35 and 44 weeks (6 months after radiotherapy)
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 .
14 secondary outcomes
Comparison of methods to follow changes in the severity of breast edema - TDC measurement
Time frame: 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
Time frame: 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
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Time to edema onset
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Time to edema disappearance
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Symptoms and quality of life changes associated with breast edema
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Breast edema hypersensitivity
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Breast pain
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Skin changes associated with breast edema
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Physical activity
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Healing time
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Safety of the device
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Compliance to the device
Time frame: Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy)
Patient's satisfaction
Time frame: 3 weeks after surgery and 6 months after radiotherapy (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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.
- Background: PubMed 31360894Young-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.
- Background: PubMed 25164973Verbelen 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.
- Background: PubMed 33775252Verbelen 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.
- Background: PubMed 31233373Johansson 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.
- Background: PubMed 31211631Gregorowitsch 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.
- Background: PubMed 31659592Verbelen 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.
- Background: PubMed 33761280Mayrovitz 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.
- Background: PubMed 34455642Kilbreath 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.
- Background: PubMed 31596657Yu 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.
- Background: PubMed 18077074Delay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Séverine ALRAN, Dr principal investigator
Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobiderm Intimate Bra group in people with Breast Cancer Surgery, run by Thuasne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of breast edema severity (time frame: Between 35 and 44 weeks (6 months after radiotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06303154, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.