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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Thuasne
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evolution of breast edema severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 years and older.
- •Patients who have undergone conserving surgery for breast cancer.
- •Patients scheduled to undergo radiation treatment of the breast/chest wall within the next 12 weeks after surgery.
- •Patients with a morphology compatible with the proposed sizes of the devices, including bust girth and cup size.
- •Patients who have signed an informed consent form prior to any study intervention.
- •Patients with full legal capacity and enrolled in a social security system or covered by a similar health insurance.
排除标准
- •Patients with an A cup bra size.
- •Patients with infected or acutely inflammatory skin on the chest.
- •Patients who require chemotherapy during the follow-up period.
- •Pregnant women or women of childbearing age without adequate contraception or in the lactation period.
- •Participation in other clinical trials that impact the primary endpoint.
- •Patients with a known allergy to the investigational device components.
- •Patients with psychiatric, psychological, or neurological disorders that are incompatible with the conduct of a clinical trial.
- •Patients unable to be followed for 12 months.
- •Vulnerable patients, or those subject to a judicial protection measure or unable to provide informed consent freely.
结局指标
主要结局
Evolution of breast edema severity
时间窗: Between 35 and 44 weeks (6 months after radiotherapy)
The evolution of breast edema severity will be assessed all along the study follow-up using the patient-completed "Symptoms" section of the Breast Edema Questionnaire (BrEQ): 8 questions about symptoms of breast edema scored on a scale from 0 to 10 (0 = no difficulty and 10: maximal difficulty). The maximum score is 80 .
次要结局
- Comparison of methods to follow changes in the severity of breast edema - TDC measurement(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Comparison of methods to follow changes in the severity of breast edema - Clinical assessment(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Skin changes associated with breast edema(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Physical activity(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Healing time(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Safety of the device(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Compliance to the device(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Patient's satisfaction(3 weeks after surgery and 6 months after radiotherapy (end of study))
- Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Time to edema onset(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Time to edema disappearance(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Symptoms and quality of life changes associated with breast edema(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Breast edema hypersensitivity(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))
- Breast pain(Between 35 and 44 weeks (from inclusion to 6 months after radiotherapy))