Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Compare composite measurements of the face and neck for lymphatic drainage
研究概览
简要总结
This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.
详细描述
PRIMARY OBJECTIVES:
I. Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD.
II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
- •Cognitive function adequate to understand and execute the elements of the protocol
- •Willingness and ability to return to Mayo Clinic for follow-up care per protocol
- •Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
- •Must demonstrate oropharyngeal competency that would allow some oral intake
排除标准
- •Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
- •Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
- •Acute facial infection
- •Active congestive heart failure (CHF) or pulmonary edema
- •Symptomatic carotid artery disease or bradycardia
- •Increased intracranial pressure
- •History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
- •> 50% internal carotid artery (ICA) blockage
- •Upper quadrant deep vein thrombosis
- •Known esophageal obstruction
- •Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
- •Women of child-bearing potential
- •(Active) pregnancy
结局指标
主要结局
Compare composite measurements of the face and neck for lymphatic drainage
时间窗: Change from baseline and up to 12 weeks
Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
Change in lymphedema of the head and neck
时间窗: Up to 12 weeks
A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.
次要结局
- Improvements on quality of life (QOL) function(Up to 12 weeks)
- Improvements on swallowing function(Up to 12 weeks)
- Improvements on voice function(Up to 12 weeks)