Spots Global Cancer Trial Database for Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

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Trial Identification

Brief Title: Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

Official Title: Evaluation of the Performance and Safety of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment - A Prospective, Exploratory, Monocentric, Uncontrolled Clinical Study

Study ID: NCT06303154

Conditions

Breast Cancer Surgery

Interventions

Mobiderm Intimate Bra group

Study Description

Brief Summary: The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.

Detailed Description: Breast cancer is the most common malignancy in women in the Western World. BCS followed by radiotherapy is a safe and effective procedure to treat patients with early-stage \[Verbelen H., 2021\]. But some patients are troubled by breast edema in the operated and irradiated breast. The consequences of breast edema can be : an increase in breast volume, orange peel skin, heaviness of the breast, redness of the skin, breast pain, thickening of the skin, hyperpigmented skin pores \[Verbelen H., 2014\]. Breast edema can also imply deterioration in patients' quality of life, physical functioning, and body image \[Young-Afat D. A., 2019\]. According to the literature, only a few clinical studies evaluated the value of compression medical devices in the management of breast edema. The aim of the study is to perform a prospective, exploratory, monocentric, uncontrolled clinical study to look at the performance and safety of Mobiderm Intimate Bra in the management of breast edema related to breast cancer treatment.