Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
研究概览
简要总结
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
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
- 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
- •Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
- •Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
- •Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
- •Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
- •Participants must be willing to participate in the swallowing exercise program
- •Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
- •Previous radiation treatment for head/neck cancer
- •Swallowing problem of etiology other than current lesion
- •Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
排除标准
- 未提供
研究组 & 干预措施
Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
干预措施: exercise intervention (Behavioral)
Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
干预措施: questionnaire administration (Other)
Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
干预措施: quality-of-life assessment (Procedure)
Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
干预措施: exercise intervention (Behavioral)
Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
干预措施: questionnaire administration (Other)
Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
时间窗: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
次要结局
- Eating Assessment Tool (EAT) quality of life score(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Percent weight loss(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Penetration Aspiration Scale (PAS) as assessed via FEES(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Lingual strength as assessed by lingual manometry(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Percent weight recovery(Baseline and at 1, 3, and 6 months following completion of radiotherapy)
- Feeding tube duration (days)(Baseline and at 1, 3, and 6 months following completion of radiotherapy)