A Prospective Randomized Single Blind Phase III Trial Comparing Flexitouch Home Maintenance Therapy to Standard Home Maintenance Therapy for Lower Extremity Lymphedema Resulting From Treatment of Gynecologic Malignancy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Lower-extremity Volumes for Both Unaffected and Affected Legs
研究概览
简要总结
This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.
详细描述
PRIMARY OBJECTIVE:
I. Compare the effectiveness of the Flexitouch® System to standard home lymphedema therapy (Manual Lymphatic Drainage) in the management of lower-extremity lymphedema in women with a history of cervical, vulvar, or endometrial cancer.
SECONDARY OBJECTIVE:
I. Compare the quality of life (QOL) and functional status between patients using the Flexitouch® System and those following standard home lymphedema treatment (Manual Lymphatic Drainage) programs in the management of lower-extremity lymphedema
OUTLINE: This is a multicenter study. Patients are stratified according to site of cancer (cervical vs vulvar vs endometrial) and stage of lymphedema at diagnosis. Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy.
- •At least 6 months since clinic therapy for lower-extremity lymphedema
- •Is within 3 years from finishing cancer treatment
- •No active or recurrent cancer
- •More than 3 months since cancer treatment
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
干预措施: Management of Therapy Complications (Procedure)
Arm 1
Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
干预措施: Quality-of-Life Assessment (Other)
Arm II
Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
干预措施: Management of Therapy Complications (Procedure)
Arm II
Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Lower-extremity Volumes for Both Unaffected and Affected Legs
时间窗: From registration to study discontinuation. A maximum of 7 months.
Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.
次要结局
- Need for Unscheduled Visits at the Patients' Lymphedema Clinic(From registration to study discontinuation. A maximum of 7 months.)
- Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire(From registration to study discontinuation. A maximum of 7 months.)
- Compliance With Treatment as Assessed by the Number of Days Per Week Using MLD or Flexitouch System and Duration/Day of MLD and Flexitouch System Treatment(From registration to study discontinuation. A maximum of 7 months.)
- Incidence of Deep-vein Thrombosis(From registration to study discontinuation. A maximum of 7 months.)
- Incidence of Cellulitis(From registration to study discontinuation. A maximum of 7 months.)
- Pain in Affected Limb(From registration to study discontinuation. A maximum of 7 months.)