Lymphedema in Patients With Oral Cavity and Oropharyngeal Cancer: Prevalence, Functional Effects, and Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Head & Neck Lymphedema Occurence
研究概览
简要总结
Objectives:
Specific Aim 1: Estimate the prevalence of head and neck lymphedema in patients who have been treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.
Compare functional outcomes in patients with and without lymphedema using cross-sectional survey methods.
Specific Aim 2: Evaluate the effect of Complete Decongestive Therapy (CDT) provided in an outpatient setting or a home-based program in reducing lymphedema in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer at 1, 3 and 6 months follow-up. Patient characteristics, treatment variables, and the health care environment will be analyzed as possible explanatory variables that influence the effect of lymphedema treatment.
Specific Aim 3: Evaluate the effect of lymphedema treatment on symptom burden, self-image, and functional performance status in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.
详细描述
Screening for Part 1 of the Study:
The research staff will review your medical record to find out if you are possibly eligible to join Part 1 of this study. You will be eligible if you have had radiation and/or surgery (with or without chemotherapy) for mouth or throat cancer and it has been at least 1 month since your last treatment.
Part 1 of the Study:
If you choose to participate in Part 1 of this study, you will complete questionnaires. The questionnaires ask about your ability to swallow, eat, and speak, and about your quality of life, your satisfaction with your body, and any head and neck cancer symptoms. In total, the questionnaires should take less than 30 minutes to complete. You will also be asked about any symptoms of lymphedema. Your answers will be compared to the answers of patients who do and do not have lymphedema.
If you do not join Part 2 of this study, your participation in this study will be over after you complete the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult (greater than or equal to 18 years of age) patients previously treated with definitive surgical resection and/or radiation therapy with or without chemotherapy for oral and/or oropharyngeal cancer who are at least 1 month posttreatment will be eligible for enrollment.
- •Patients who meet the above requirement and are also diagnosed with head and neck lymphedema by their physician will be eligible for participation in the prospective phase of the study.
- •Patients will be free of acute tissue reactions including oral mucositis, skin breakdown, and fistula prior to inclusion in the prospective phase of the study.
- •Patients will have baseline Thyroid Stimulating Hormone testing prior to inclusion in the prospective phase of the study.
排除标准
- •Patients who are actively being treated for head and neck cancer.
- •Patients whose cancer treatment was administered with palliative intent.
- •Patients with recurrent or second primary head and neck cancer, or persistent disease. Patients who have a persistent neck mass at completion of primary radiotherapy that necessitates salvage neck dissection will be ineligible for enrollment until 1 month (6 weeks) following neck dissection.
- •Patients with any of the following contraindications to lymphedema therapy: acute infection, active cancer, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension.
- •Patients with edema related to hypothyroidism.
结局指标
主要结局
Head & Neck Lymphedema Occurence
时间窗: 30 minutes to complete questionnaires
次要结局
未报告次要终点