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

NCT03981263 | Completed

• 1 other identifier: RC31/17/0335
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Prospective study; Cross over; Quality of life; Breast; Mastectomy; Breast external prothesis; MEAVANTI prothesis

Outcome Measures

Primary Outcomes (5)

• Change in quality of life : emotional functioning

  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 from baseline to 3 months

• Change in quality of life : social functioning

  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 from baseline to 3 months

• Change in quality of life : body image

  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 from baseline to 3 months

• Change in quality of life : sexual functioning

  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 from baseline to 3 months

• Change in quality of life : satisfaction breast cosmetic

  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)

  Change from baseline to 3 months

Secondary Outcomes (6)

• Visual satisfaction

  6 months

• Evaluation of pain

  3 months and 6 months

• Comparative questionnaire

  6 months

• Collection of adverse events

  3 months and 6 months

• Costs (consultations)

  1 month, 3 Months, 4 months and 6 months

Study Arms (2)

MEAVANTI + Standard protheses

OTHER

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; Device: Standard prothesis

Standard + MEAVANTI protheses

OTHER

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

Interventions

MEAVANTI prothesis 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.

MEAVANTI + Standard protheses; Standard + MEAVANTI protheses

Standard prothesis 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.

MEAVANTI + Standard protheses; Standard + MEAVANTI protheses

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female with a breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Rangueil

Toulouse, France, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charlotte VAYSSE, MCU-PH

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over (2 periods), prospective, open and monocentric study. The wash-out period will be 15 days

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 10, 2019
• Study Start: January 28, 2021
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)