Clinical trial NCT03981263: Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Prospective study
Cross over
Quality of life
Breast
Mastectomy
Breast external prothesis
MEAVANTI prothesis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over (2 periods), prospective, open and monocentric study. The wash-out period will be 15 days
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Change in quality of life : emotional functioning
timeFrame: Change from baseline to 3 months
measure: Change in quality of life : social functioning
timeFrame: Change from baseline to 3 months
measure: Change in quality of life : body image
timeFrame: Change from baseline to 3 months
measure: Change in quality of life : sexual functioning
timeFrame: Change from baseline to 3 months
measure: Change in quality of life : satisfaction breast cosmetic
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Visual satisfaction
timeFrame: 6 months
measure: Evaluation of pain
timeFrame: 3 months and 6 months
measure: Comparative questionnaire
timeFrame: 6 months
measure: Collection of adverse events
timeFrame: 3 months and 6 months
measure: Costs (consultations)
timeFrame: 1 month, 3 Months, 4 months and 6 months
measure: Costs (paramedical procedures)
timeFrame: 1 month, 3 Months, 4 months and 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
affiliation: University Hospital, Toulouse
name: Charlotte VAYSSE, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References: