Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Changes from baseline in symptoms associated with lymphedema
研究概览
简要总结
The purpose of this study is to investigate which number of lymphedema therapy treatments/week best reduces upper extremity swelling, increased arm function, and reduces the most lymphedema symptoms.
详细描述
Complete Decongestive Therapy (CDT) is the "gold standard" in lymphedema care and has been found to be efficacious in numerous studies. These studies have varying treatment protocols of intensive phase I CDT with dosing ranging from 2x/wk for a mean of 7.5 wks to 6x/wk until a plateau in arm volumes were achieved. This variability in research does not lend itself to recommendations of evidence-based protocol use of CDT in an outpatient setting.
Although CDT is backed by efficacy studies, the daily dosing given to patients is based on anecdotal rather than evidence-based practice. Because the traditional protocol was developed from "longstanding experience," research is necessary to determine the best dosing of the intensive phase of CDT. The purpose of this study is to investigate what level of dosing in the intensive CDT phase promotes best volume reduction and increased upper extremity function in the breast cancer-related lymphedema patient population. This particular study will answer: What dosing produces best volumetric reduction and upper extremity function in the intensive phase of complete decongestive therapy for outpatients with breast cancer-related lymphedema 2x/wk for 4wks or 4x/wk for 4 wks?
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have active unilateral breast cancer-related lymphedema
- •Medically stable
- •Have not participated in lymphedema therapy the past 3 months
- •An affected limb volume measurement of >10% excess volume
- •Ages 18-95 years old
- •Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.
- •Patients with any stage breast cancer will be included in this study.
- •Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.
- •All subjects must have given signed, informed consent prior to registration on study.
排除标准
- •Prophylactic treatment indicated
- •A presence of upper extremity wounds present
- •Active signs of infection or deep vein thrombosis (DVT)
- •Bilateral lymphedema present
- •Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency
- •Severe lymphedema present as defined by > 30% increase in limb volume
研究组 & 干预措施
Treatment 2x/wk
Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.
干预措施: Standard of care complete decongestive therapy (Other)
Treatment 4x/wk
Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.
干预措施: Standard of care complete decongestive therapy (Other)
结局指标
主要结局
Changes from baseline in symptoms associated with lymphedema
时间窗: At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks)
This outcome measure will assess the presence of symptoms associated with lymphedema.
Change from baseline in impairments in function, activity limitations, and participation restrictions
时间窗: At first treatment appointment (roughly week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks)
A questionnaire looking at impairments in function, activity limitations, and participation restrictions consists of 29 questions divided into five domains: physical function, mental function, household activities, mobility activities, and life and social activities.
次要结局
- Changes from baseline in lymphedema volume(At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks))
研究者
Katie M. Polo, MHS, OTR/L, CLT-LANA
Sponsor Investigator
University of Indianapolis