A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Fidelity/Adherence Via Subject Diary
研究概览
简要总结
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
详细描述
This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. The study will be conducted at up to 2 sites in the United States and enroll 40 subjects with a diagnosis of head and neck lymphedema following treatment for head and neck cancer. Subjects randomized to receive daily treatment with the Flexitouch pneumatic compression device and home care regimen (SOC) will be seen at baseline and weeks 1, 4, and 8. Subjects randomized to the wait list arm will be seen at baseline and weeks 1, 4, and 8 while receiving SOC treatment. Assessments will include fidelity, satisfaction, symptoms, swelling/inflammation, function, and QOL.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •A previous diagnosis of histologically defined head and neck cancer.
- •A diagnosis of head and neck lymphedema.
- •Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
- •Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
- •The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
- •The subject must have experienced at least one of the following:
- •Completion of phase 1 lymphedema care in the past 8 weeks;
- •The inability to participate/complete phase 1 care due to:
- •Lack of available therapist/clinic,
- •Lack of insurance coverage or funding to support cost of care.
排除标准
- •Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression).
- •Carotid sinus hypersensitivity syndrome.
- •Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness).
- •Symptomatic bradycardia in the absence of a pacemaker.
- •Internal jugular venous thrombosis, acute or within 3 months.
- •Increased intracranial pressure or other contraindications to internal or external jugular venous compression.
- •Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative.
- •Facial or head and neck dermal metastasis.
- •Acute facial infection (e.g., facial or parotid gland abscess).
- •Any condition in which increased venous and lymphatic return is undesirable.
- •History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
- •Subject is pregnant or trying to become pregnant.
研究组 & 干预措施
Standard of Care
Standard home lymphedema care
干预措施: Standard home lymphedema care (Other)
Flexitouch head and neck lymphedema treatment system
Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care
干预措施: Flexitouch head and neck lymphedema treatment system (Device)
结局指标
主要结局
Fidelity/Adherence Via Subject Diary
时间窗: From baseline to end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.
Adverse Events
时间窗: From baseline to the end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.
Treatment Satisfaction
时间窗: From baseline to the end of treatment at 8 weeks
Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.
次要结局
- Reduction in Swelling/Inflammation - Endoscopy(From baseline to the end of treatment at 8 weeks)
- Reduction in Swelling/Inflammation - Cytokine Levels(From baseline to the end of treatment at 8 weeks)
- Reduction in Swelling/Inflammation - Digital Photography(From baseline to the end of treatment at 8 weeks)
- Function - Cervical and Shoulder Range of Motion(From baseline to the end of treatment at 8 weeks)
- Reduction in Swelling/Inflammation - Grading of External Lymphedema(From baseline to the end of treatment at 8 weeks)
- Function - Jaw Range of Motion(From baseline to the end of treatment at 8 weeks)
- Function - Neck Disability Index(From baseline to the end of treatment at 8 weeks)
- Function - Voice Handicap Index(From baseline to the end of treatment at 8 weeks)
- Symptoms - Vanderbilt Head and Neck Symptom Survey(From baseline to the end of treatment at 8 weeks)
- Quality of Life - Linear Analog Self-Assessment(From baseline to the end of treatment at 8 weeks)
- Symptoms - Lymphedema Symptom Intensity and Distress Survey(From baseline to the end of treatment at 8 weeks)