NCT05911854已完成不适用
Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 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.
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
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary DiseaseCOVID-19NCT04391712Lowell General Hospital10
进行中（未招募）
不适用
LaseMD System for the Treatment of MelasmaMelasmaNCT03456674LUTRONIC Corporation10
已完成
不适用
Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral NeuropathyPeripheral NeuropathyNCT01006408Legacy Health System20
已完成
不适用
The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised PatientsOrthodonticsPeriodontal DiseasesNCT03765151The University of Hong Kong35
已完成
不适用
Treatment of Class II Malocclusion Combined With Low-level LaserMalocclusion, Angle Class IINCT03239912Damascus University40