A reserch of high resolution manometory after chemoradiotherapy for patients with head and neck cancer
- Conditions
- Head and Neck cancer
- Registration Number
- JPRN-jRCT1052190068
- Lead Sponsor
- ibu Ken-ichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Patients who satisfy all the following criteria are targeted.
(1) Patients diagnosed with squamous cell carcinoma of the head and neck
(2) Completion of chemoradiotherapy as first-line radical treatment
(3) Patients whose age is 20 years or older at the start of chemoradiotherapy
(4) Those who have passed without recurrence / metastasis for a period from the completion of chemoradiotherapy until the consent of this study is obtained
(5) Severity / progression level at initial treatment: no question
(6) Gender: no question
(7) Hospitalization / outpatient: no question
(8) Patients who obtained document consent by their voluntary free will concerning participation in this exam
Patients applicable to even one of the following are excluded.
(1) Patients who had a clear decline in swallowing function due to other diseases before awareness of the tumor
(2) Other history of head and neck cancer or esophageal cancer (excluding superficial cancer)
(3) Patients with a history of xylocaine allergy
(4) Pregnant women and patients who may be pregnant or breast-feeding patients
(5) Patients suffering from or having a history of severe heart disease such as lethal arrhythmia and ischemic heart disease
(6) Patients suffering from or having a history of hepatitis B virus, who have not been evaluated / treated by gastroenterologists
(7) Patients who can not insert the device from the nasal cavity due to nasal / nasal sinus disease
(8) In addition, patients judged inappropriate by the person in charge of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure the swallowing pressure at 3 months and 12 months after completion of chemoradiotherapy and describe the measured value. Evaluate the amount of rate between 2 points (analyzed divided into the nasopharynx, oro-hypo pharynx, cervical esophagus).
- Secondary Outcome Measures
Name Time Method FEES<br>Videofuluoroscopy<br>Blowing time ratio<br>EAT-10<br>Adverse event information