Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Arm Volume at End of Study
研究概览
简要总结
No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema.
Hypotheses:
Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance & arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System.
H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System.
H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System.
H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire [FASQ] will improve after 10 sessions with the Flexitouch® System.
Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance & arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).
H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only).
H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) .
H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).
详细描述
Screening Procedures This study will have a three-phase screening process.
Phase One:
Participants will be screened either in person or via the telephone.
Phase Two:
If the person being interviewed is eligible and interested, study staff will obtain phone consent for a brief interview to obtain basic medical and treatment information and to share this information with the study doctor, who will write prescriptions for treatment based upon these data. After a prescription is obtained, study staff will contact participants by phone and schedule the on-site visit.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at least six months post- surgery and/or radiation treatment for breast cancer
- •At least 21 years of age
- •Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling ** (Part One) and *lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two)
- •Willing and able to drive to the study site as needed
- •Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist
排除标准
- •Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy
- •Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms
- •History of bilateral breast cancer
- •Metastatic cancer
- •Inability to stand upright
- •Metal implants that would interfere with bioimpedance measurement equipment
- •Pacemaker and internally implanted defibrillators
研究组 & 干预措施
arm, trunk and chest compression
Intervention of arm, trunk and chest compression by Flexitouch System
干预措施: Flexitouch System (Device)
arm compression only
Intervention of arm compression only by Flexitouch System
干预措施: Flexitouch System (Device)
结局指标
主要结局
Arm Volume at End of Study
时间窗: end of scheduled treatments-day 30 of treatment
measured by tape and then volume was calculated.
次要结局
- Symptom Improvement(Before first treatment and end of all treatments)
研究者
Sheila Ridner
Associate Professor
Vanderbilt University