DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 18
- 主要终点
- Percent reduction in excess arm volume as calculated from circumferential arm measurements
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema.
This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage.
Duration: One year after the last patient is randomized.
详细描述
Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
- •Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment.
排除标准
- •Clinical or radiological evidence of active disease, either local or metastatic.
- •History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
- •Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).
- •Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
- •Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
- •Patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm.
- •Unable to commence therapy within 7 days of randomization.
- •Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
研究组 & 干预措施
2
Standard of Care
1
Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy)
干预措施: Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) (Procedure)
结局指标
主要结局
Percent reduction in excess arm volume as calculated from circumferential arm measurements
时间窗: at 6 weeks
次要结局
- Measurement of arm function(Midtreatment,6,12 24,52 weeks)
- Quality of life(Midtreament, 6 12,24,52 weeks)