A reserch of high resolution manometory after chemoradiotherapy for patients with head and neck cancer

JRCT ID: jRCT1052190068

Registered date:23/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and Neck cancer
• Date of first enrollment: 23/05/2018
• Target sample size: 25
• Study type: Interventional
• Intervention(s): twice examination of high resolution manometory at 3M and 12M after CCRT

Outcome(s)

• Primary Outcome: 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

FEES
Videofuluoroscopy
Blowing time ratio
EAT-10
Adverse event information

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Nibu Ken-ichi
• Secondary ID(s): UMIN000030506