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Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. (MEAVANTI)

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ClinicalTrials.gov Identifier: NCT03981263
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: MEAVANTI prothesis Device: Standard prothesis Not Applicable

Detailed Description:

In France, breast cancer is a public health issue with around 59,000 new cases per year. Despite improved surgical techniques, there is still around 30% mastectomy performed every year. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the use of external breast prosthesis. Currently, there are 3 silicone brands that are marketed and refunded. These standard prostheses take into account only the curve of the patients and not the weight of the remaining breast making adaptation difficult to all body types. The difference in breast weights can cause several disorders: postural, pain, discomfort, psychological impact on quality of life as well as medico-economic impact. MEAVANTI is an external breast prosthesis for custom calibration and personalization, which can prevent postural compensation and provide greater comfort.

The main objective of this study is therefore to evaluate whether the MEAVANTI prosthesis improves the quality of life of patients who have undergone a mastectomy compared to the standard prosthesis (through the EORTC questionnaires - European Organization for Research and Treatment of Cancer). This study will be monocentric, cross-over (2 periods), prospective, open with a wash-out period of 15 days. The period of the study will be conducted over 13 months.

The expected benefits can be major. The main benefit expected is the improvement of quality of life of the patients carrying the MEAVANTI breast prosthesis compared to those carrying the so-called standard prosthesis. A reduction in back and neck pain could also reduce the costs of patient management. In addition, this will demand referencing by the HAS of the custom-made prosthesis so that it is reimbursed in the same way as existing ones.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over (2 periods), prospective, open and monocentric study. The wash-out period will be 15 days
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. MEAVANTI Project.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MEAVANTI + Standard protheses
The patients will benefit from the experimental prothesis (MEAVANTI), after a wash-out period of 15 days, they will benefit from the standard non-adherent prothesis.
Device: MEAVANTI prothesis

The experimental prosthesis is the MEAVANTI prosthesis ("custom-made" non-adherent prosthesis in silicone) which can be calibrated to 5 grams near the breast that remains after a mastectomy to create a visual symmetry but also a weight symmetry.

This prosthesis takes into account the curve of the breasts and the morphological details such as: skin color of the patients, size of the nipples, height of the nipples, shape of the breast.

The measurements of the patients will be taken using a 3D scanner (i.e. a scanner that corresponds to a 3d scanning and acquiring device (images), not irradiating), a scale and a colour chart.


Device: Standard prothesis
This prosthesis will be compared with a standard non-adherent prosthesis (class I, silicone and polyurethane film), among the models available in the three ranges of standard prostheses (Amoena, Anita and Thuasne). The brand and model will be left to the patient's choice.

Standard + MEAVANTI protheses
The patients will benefit from the standard non-adherent prothesis, after a wash-out period of 15 days, they will benefit from the experimental prothesis (MEAVANTI).
Device: MEAVANTI prothesis

The experimental prosthesis is the MEAVANTI prosthesis ("custom-made" non-adherent prosthesis in silicone) which can be calibrated to 5 grams near the breast that remains after a mastectomy to create a visual symmetry but also a weight symmetry.

This prosthesis takes into account the curve of the breasts and the morphological details such as: skin color of the patients, size of the nipples, height of the nipples, shape of the breast.

The measurements of the patients will be taken using a 3D scanner (i.e. a scanner that corresponds to a 3d scanning and acquiring device (images), not irradiating), a scale and a colour chart.


Device: Standard prothesis
This prosthesis will be compared with a standard non-adherent prosthesis (class I, silicone and polyurethane film), among the models available in the three ranges of standard prostheses (Amoena, Anita and Thuasne). The brand and model will be left to the patient's choice.




Primary Outcome Measures :
  1. Change in quality of life : emotional functioning [ Time Frame: Change from baseline to 3 months ]
    Emotional dimension will be studied with items from 21 to 24 of EORTC Quality of Life Questionnaire QLQ-C30 (Generic Questionnaire) (Likert type with 4 choices from 1 = not at all to 4 = a lot)

  2. Change in quality of life : social functioning [ Time Frame: Change from baseline to 3 months ]
    Social dimension will be studied with items from 26 and 27 of EORTC Quality of Life Questionnaire QLQ-C30 (Generic Questionnaire) (Likert type with 4 choices from 1 = not at all to 4 = a lot)

  3. Change in quality of life : body image [ Time Frame: Change from baseline to 3 months ]
    Body image will be studied with items from 39 to 42 of EORTC Quality of Life Questionnaire BR23 Module (Breast Cancer Module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)

  4. Change in quality of life : sexual functioning [ Time Frame: Change from baseline to 3 months ]
    Sexual functioning will be studied with items from 56 to 59 of EORTC Quality of Life Questionnaire BRECON 14 (Reconstruction module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)

  5. Change in quality of life : satisfaction breast cosmetic [ Time Frame: Change from baseline to 3 months ]
    Satisfaction breast cosmetic will be studied with items from 60 to 65 of EORTC Quality of Life Questionnaire BRECON 14 (Reconstruction module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)


Secondary Outcome Measures :
  1. Visual satisfaction [ Time Frame: 6 months ]
    Evaluation of the visual satisfaction associated with wearing of the external prosthesis by the self and the hetero-evaluation (from photos taken of the patient (face, profiles, ¾ with and without the prosthesis): carried out by a scale of judgment (Likert type with 5 choices from 1 = very satisfied to 5 = very unsatisfied) at 6 months.

  2. Evaluation of pain [ Time Frame: 3 months and 6 months ]
    Evaluation of pain by the analogical EVA scale 1 to 10, on the following 3 sites: back / shoulders / cervical at 3 monts and 6 months.

  3. Comparative questionnaire [ Time Frame: 6 months ]
    Comparative questionnaire "adhoc" between the 2 prostheses will be performed at 6 months (that is to say at the end of the study) targeting specific issues to the wearing of prostheses (previously used by the HAS for the referencing of silicone prostheses). This questionnaire consists of 14 questions, type Likert 5 points.

  4. Collection of adverse events [ Time Frame: 3 months and 6 months ]
    Adverse events will be recorded

  5. Costs (consultations) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for consultations will be raised

  6. Costs (paramedical procedures) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for paramedical procedures will be raised



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female with a breast cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral mastectomy performed.
  • Satisfactory healing
  • Informed consent form signed.
  • Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

  • Elastomer type plastics or silicone allergy
  • Contraindication to the use of the MEAVANTI or Standard external prosthesis: damaged or irritated skin in the area of application of the prosthesis
  • Patient under the age of 18 years
  • History of back problems (scoliosis)
  • History of spine surgery
  • Other cancer being treated,
  • Dorsal hyperalgia
  • Acute infectious episode (cellulitis, erysipelas, lymphangitis)
  • Presence of subcutaneous osteosynthesis material with an external part at the level of the upper limb to be treated,
  • Impossibility to comply with the constraints of the protocol,
  • Pregnancy,
  • Breast feeding
  • Adult protected by law (tutelage, curators and safeguard of justice).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981263


Contacts
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Contact: Charlotte VAYSSE, MCU-PH 5 31 15 53 84 ext 33 vaysse.c@chu-toulouse.fr
Contact: Eva JOUVE, PH 5 31 15 60 24 ext 33 jouve.eva@iuct-oncopole.fr

Locations
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France
CHU Rangueil Not yet recruiting
Toulouse, France, 31059
Contact: Charlotte VAYSSE, MCU-PH    05 31 15 53 84 ext 33    vaysse.c@chu-toulouse.fr   
Principal Investigator: Charlotte Vaysse, MCU-PH         
Sub-Investigator: Eva Jouve, PH         
Sub-Investigator: Elodie Chantalat, MCU-PH         
Sub-Investigator: Gabrielle Selmes, PH         
Sub-Investigator: André Benoit, PH         
Sub-Investigator: Thomas Meresse, PH         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Charlotte VAYSSE, MCU-PH University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03981263     History of Changes
Other Study ID Numbers: RC31/17/0335
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Prospective study
Cross over
Quality of life
Breast
Mastectomy
Breast external prothesis
MEAVANTI prothesis