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临床试验/NCT07434245
NCT07434245已完成不适用

İnvestigation of the Effect of Neck Endurance on Swallowing and Directional Coordination in Head and Neck Cancer Patients

Istanbul Arel University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
FEES

研究概览

简要总结

In the study, it was aimed to evaluate the relationship between dysphagia, which is one of the treatment complications, and the variables of respiratory performance, intraoral pressure and neck endura, and to look at the future work and rehabilitation methods of these evaluation outcomes from a different parameter.

详细描述

Head and neck cancers; oral cancers, pharyngeal cancers, laryngeal cancers, salivary gland cancers, and cancers involving the skin of the head and neck region. Head and neck cancer treatment options include surgery, radiotherapy, and chemotherapy.

Dysphagia, that is, difficulty in swallowing, is a symptom that affects the quality of life, which is often neglected in patients with head and neck cancer. 40% of patients suffer from dysphagia during and after treatment. Dysphagia causes serious complications such as aspiration, malnutrition and even death, in addition to causing increased health expenditures with a decrease in the quality of life.

Swallowing and respiration are two vital functions coordinated with each other, ensuring coordination is vital.

When the respiratory-swallowing relationship was examined in HNC patients, the patient's breathing was examined through swallowing apnea, but respiratory performance was not evaluated through intraoral pressure and respiratory function test.

Swallowing dysfunctions are frequently seen in patients with head and neck cancer, both due to the pathophysiology of the disease and because the treatments applied due to the localization of the tumor affect the head and neck region, and the quality of life is low because these patients cannot reach rehabilitative approaches. In studies on the effects of chemotherapy and radiotherapy, which are included in the treatment of head and neck cancer patients, it has been proven in the literature that it causes a decrease in swallowing performance and neck endurance over time.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosing head and neck cancer patients (larynx, nasopharynx, tongue, tonsil, parotid, retromolar trigone, lip, tongue root, hypopharyngeal cancers)
  • Statement with consent considering participating in the study
  • Disorders that cause obstacles due to the Function Test and intraoral passages

排除标准

  • Presence of a chronic disease that prevents participation in the pulmonary function test and the study by the radiation oncology doctor and otolaryngologist.
  • Patients with swallowing problems due to previous illness or surgery
  • Acute surgical patient

研究组 & 干预措施

Head and Neck Cancer Patients without Swallowing Disorder

This group has 0 between 3 score in EAT-10 Scale.

干预措施: Fiberoptic Endoscopic Evaluate Swallowing (Diagnostic Test)

Head and Neck Cancer Patients with Swallowing Disorder

This group has 4 between 40 score in EAT-10 Scale.

干预措施: Fiberoptic Endoscopic Evaluate Swallowing (Diagnostic Test)

结局指标

主要结局

FEES

时间窗: through study completion, an average of 6 months.

Fiberoptic Endoscopic Evaluate Parametres ( PAS, Yale Residue Scale, Murray Secretion Scale)

EAT-10 Scale

时间窗: through study completion, an average of 6 months.

This scale includes 10 questions.

Neck arthrokinematics assessment

时间窗: through study completion, an average of 6 months.

Neck Endurance Test (30s), Neck ROM, Neck Disability İndex

Respiratory Function Test

时间窗: through study completion, an average of 6 months.

FEV1, FEV1/FVC, FVC, PEF

İntraoral Mouth Pressure

时间窗: through study completion, an average of 6 months.

MIP, MEP

次要结局

未报告次要终点

研究者

发起方
Istanbul Arel University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabia KUM GULER

Philosophiae Doctor PhD candidate (c)

Istanbul Arel University

研究点 (1)

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