Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Perimetry
研究概览
简要总结
Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.
详细描述
This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way
Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.
Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.
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
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery.
- •Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer.
排除标准
- •To have received lymphedema treatment previously.
- •To be treated by radiation therapy or chemotherapy.
- •Distant metastases or local recurrence of cancer.
- •Infectious signs in the upper limb with lymphedema.
- •Uncontrolled hypertension.
- •Heart disease.
结局指标
主要结局
Perimetry
时间窗: Baseline, 6 weeks and 12 weeks
Arm volume is measured with perimetry through truncation of cones formula
次要结局
- Handgrip strength(Baseline, 6 weeks and 12 weeks)
- Multiple sit-to-stant test(Baseline, 6 weeks and 12 weeks)
- Degree of pain(Baseline, 6 weeks and 12 weeks)
- Pulmonary function test(Baseline, 6 weeks and 12 weeks)
- Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)(Baseline, 6 weeks and 12 weeks)
- Six-minute walking test(Baseline, 6 weeks and 12 weeks)
- FACT-B+4 questionnaire(Baseline, 6 weeks and 12 weeks)
- EORTIC-QLQ-C30 questionnaire(Baseline, 6 weeks and 12 weeks)
- QLQ BR23 questionnaire(Baseline, 6 weeks and 12 weeks)
- HADS questionnaire(Baseline, 6 weeks and 12 weeks)
- QuickPIPPER questionnaire(Baseline, 6 weeks and 12 weeks)
- The short version of the IPAQ(Baseline, 6 weeks and 12 weeks)
- Qualitative measures(6 weeks)
- Smartphone-based application(Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks)
研究者
Rocío Martín Valero
Ph D
University of Malaga