Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
研究概览
简要总结
This study was conducted:
- To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To investigate the effect of CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To compare the effect of MLS Laser versus CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Female patients with unilateral BCRL.
- •Age of patients above 18 years old
- •Patient history of modified radical mastectomy, chemotherapy and/or radiotherapy.
- •Patients undertaken have history or current hormonal treatment.
- •Patients with moderate lymphoedema (20-40% increase in extremity volume)
排除标准
- •Patients who have severe co-morbid diseases.
- •Presence of other cancers, cancer recurrence, lymphatic malformation, or vascular disease
- •Patients who are having current chemotherapy and/or radiotherapy.
- •Patients who have bilateral lymphedema, current metastases, elephantiasis, infection, lymphangiosis carcinomatosa, cellulitis, venous thrombosis, or congestive heart failure
- •Patients with musculoskeletal disorders affecting upper extremity.
研究组 & 干预措施
Study group (A) Multi-waved Locked System Laser group
干预措施: Multi-waved Locked System Laser (Device)
Study group (A) Multi-waved Locked System Laser group
干预措施: complete decongestive therapy (Other)
Study group (B) Cold Compression Therapy group
干预措施: Cold Compression therapy (Device)
Study group (B) Cold Compression Therapy group
干预措施: complete decongestive therapy (Other)
Group (C) Control group
干预措施: complete decongestive therapy (Other)
结局指标
主要结局
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
时间窗: Baseline
Interpretation of the results of the lymphoscintigraphy and using the contralateral limb as a healthy control with normal lymphatic function can differentiate the lymphatic flow abnormalities into 7 stages
The change of Volumetric measurement of the arm pre and post treatment
时间窗: Baseline
Precise arm volume measurement is capital in the follow-up of breast cancer patients, as an early detection of BCRL can reduce the incidence of irreversible stages
次要结局
- The change of Lymphedema Life Impact Scale scores pre and post treatment(Baseline)
研究者
Sherine Omar Abdelaziz Mohamed Elsherif
assistant lecturer
Cairo University