The Effect of Manual Lymph Drainage in the Treatment of Breast Edema That May Occur in Patients Undergoing Breast-conserving Surgery and Adjuvant Radiotherapy-Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Breast edema questionnaire
研究概览
简要总结
Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
- •Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
- •Female patients between the ages of 18-75
- •Patients who cannot read and write Turkish
排除标准
- •A previous cancer
- •Decompensated heart failure
- •Untreated congestive heart failure
- •Active infection
- •Uncontrolled hypertension
- •Acute kidney failure
- •Patients with acute deep vein thrombosis
- •Metastasis and/or recurrence during treatment
- •Patients who have undergone another surgery related to the breast and chest area
- •Patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.
结局指标
主要结局
Breast edema questionnaire
时间窗: Change from baseline breast edema questionnaire at 12 weeks
Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points.
Clinical features of breast cancer and breast edema
时间窗: Change from baseline clinical features of breast cancer and breast edema at 12 weeks
The presence of breast fibrosis or edema, teleangiectasia or dyspigmentation will be scored on a 4-point categorical scale. The scale will be in the range of 0-16 points, high scores will indicate worsening of breast edema, and low scores will indicate improvement.
Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23
时间窗: Change from baseline Quality of life (EORTC- BR23) test at 12 weeks
The EORTC-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.
LENT-SOMA criteria in breast edema
时间窗: Change from baseline LENT-SOMA criteria at 12 weeks
Breast Cancer Conservative treatment core objective measurement. It has a score between 13-52 points. As the score increases, it is seen that breast edema worsens. A decrease in the score indicates improvement in breast edema.
次要结局
- Breast pain intensity will be measured with the Visual Analog Scale(Change from baseline Visual Analog Scale test at 12 weeks)
- Quality of life test (EORTC QOL-C30)(Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks)
研究者
Nuray Alaca
Assoc Prof. Nuray Alaca
Acibadem University