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

NCT ID: NCT03981263

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2024-10-24

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

MEAVANTI prothesis

Intervention Type: DEVICE

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.

Standard prothesis

Intervention Type: DEVICE

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).

Group Type: OTHER

MEAVANTI prothesis

Intervention Type: DEVICE

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.

Standard prothesis

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlotte VAYSSE, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Rangueil

Toulouse, France, France

Countries

France

Other Identifiers

RC31/17/0335

Identifier Type: -

Identifier Source: org_study_id