MEAVANTI: Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis.

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03981263

Collaborator

(none)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 daysCross-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.

Actual Study Start Date :

Jan 28, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: 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

Device: Standard prothesis

Outcome Measures

Primary Outcome Measures

Change in quality of life : emotional functioning [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)
Change in quality of life : social functioning [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)
Change in quality of life : body image [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)
Change in quality of life : sexual functioning [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)
Change in quality of life : satisfaction breast cosmetic [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

Visual satisfaction [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.
Evaluation of pain [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.
Comparative questionnaire [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.
Collection of adverse events [3 months and 6 months]
Adverse events will be recorded
Costs (consultations) [1 month, 3 Months, 4 months and 6 months]
Costs for consultations will be raised
Costs (paramedical procedures) [1 month, 3 Months, 4 months and 6 months]
Costs for paramedical procedures will be raised

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).