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Clinical Trials/jRCTs052220011
jRCTs052220011RecruitingNot Applicable

Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE)

Not provided0 sites40 target enrollmentStarted: June 15, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Primary Endpoint
The amount of change in the maximum tongue pressure value
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Treatment Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
18age old over to 85age old under (—)
Sex
All

Inclusion Criteria

  • •Patients with oropharynx or hypopharynx cancer (regardless of tissue system) who undergo chemoradiation treatment or radiation treatment as the first curative treatment. But, patients who have undergone chemotherapy prior to chemoradiation treatment or radiation treatment are included.
  • •Age: 18 to 85 years old
  • •Performance Status (ECOG) is 0 or 1 (within one month prior to obtaining consent)
  • •Patients with written consent for participation of this clinical study from the patient or its representative

Exclusion Criteria

  • •Patients whose don't recognize measurer's instructions (e.g. patients with dementia, aphasia, aphasia, higher brain dysfunction, intellectually disabled, etc.)
  • •Patients who can't grip the tongue pressure probe with the front teeth (e.g. patients who are toothless jaws and are not wearing dentures)
  • •Patients who can't crush the tongue pressure probe (e.., patients who cannot move the tongue at all)
  • •Patients with dysphagia du to the pretreatment for head and neck cancer
  • •Patients with significant decrease in swallowing function due to a history of central diseases, etc.
  • •Other patients who are judged inadequate to this research by the principal (sub) investigator

Outcomes

Primary Outcomes

The amount of change in the maximum tongue pressure value

Time Frame: before radiation treatment and 3 months after the end of treatment (Before treatment is defined as the time from obtaining informed consent to the start of radiation treatment. After treatment is at the time 3 months plus and minus 14 days after the end of radiation treatment).

The maximum tongue pressure value is the maximum value in the 3 times mesurement.

Secondary Outcomes

  • Evaluation by swallowing endoscopy(each point)
  • Swallowing disorder findings by swallowing imaging examination(each point)
  • The amount of change in the maximum tongue pressure value(1 month after the start of radiation treatment and 0, 1, or 6 months after the end of treatment)

Investigators

Sponsor
Not provided

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