Randomized Controlled Trial to compare efficacy of Decongestive CompressionTherapy and injection Benzathine Penicillin G vs Decongestive CompressionTherapy, injection Benzathine Penicillin - G and Placement of Hydrophobic Siliconetube in upper limb Lymphedema following ALND in breast cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb
研究概览
简要总结
Lymhedema is unavoidable complication post ALND in breast cancer. Staganation of lymph takes place in the arm, with the result, the arm becomes heavy which decreases the movement at joints and deteriorates the quality of life.
Standard of treatment at present is Decongestive Compression Therapy which helps the patient to some extent only. Alternate ways of therapy are being explored that will evacuate the lymph from the lymphedema arm,
resulting in decrease in volume and limb girth, and therefore improve their quality of life. So this is an attempt to use silicone tubes as a artificial lymphatic for drainage of lymph to be placed surgically from dorsum of the hand
to scapular region (Non lymphedema area).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •All operated cases of breast cancer with established upper limb lymphedema of stage 2 and 3 coming to surgery OPD between May 2017 to Dec 2018 will be recruited after proper screening.
排除标准
- •Pre operative difference of >2cm in both upper limbs circumference if documented .
- •Upper limb swelling because of deep vein thrombosis
- •Peripheral arterial disease with involvement of upper limb.
- •Refusals for consent.
- •Known allergy to Penicillin.
结局指标
主要结局
Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb
时间窗: Baseline, 1 month, 3 months, and 6 months of the follow up | period.
girth by measuring with tap along the length of arm every 5 cm and volume measurement by water displacement menthod
时间窗: Baseline, 1 month, 3 months, and 6 months of the follow up | period.
次要结局
- 1. Improvement in range of movement of shoulder- assessed by degree of pain free movement using(a goniometer .)