Skip to content

ELEVATE study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052220011
Enrollment
40
Registered
2022-04-22
Start date
2022-06-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oropharynx cancer or hypopharynx cancer head and neck cancer, opharynx cancer, hypopharynx cancer

Interventions

tongue pressure mesurement Swallowing rehabilitation

Sponsors

Uemura Hirokazu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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. 2. Age: 18 to 85 years old 3. Performance Status (ECOG) is 0 or 1 (within one month prior to obtaining consent) 4. Patients with written consent for participation of this clinical study from the patient or its representative

Exclusion criteria

Exclusion criteria: 1. Patients whose don't recognize measurer's instructions (e.g. patients with dementia, aphasia, aphasia, higher brain dysfunction, intellectually disabled, etc.) 2. 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) 3. Patients who can't crush the tongue pressure probe (e.., patients who cannot move the tongue at all) 4. Patients with dysphagia du to the pretreatment for head and neck cancer 5. Patients with significant decrease in swallowing function due to a history of central diseases, etc. 6. Other patients who are judged inadequate to this research by the principal (sub) investigator

Design outcomes

Primary

MeasureTime frame
The amount of change in the maximum tongue pressure value 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

MeasureTime frame
1. The amount of change in the maximum tongue pressure value from 1 month after the start of radiation treatment and 0, 1, or 6 months after the end of treatment. 2. Evaluation by swallowing endoscopy at each point (Hyodo score) 3. Swallowing disorder findings by swallowing imaging examination at each point

Contacts

Public ContactHirokazu Uemura

Nara Medical University Hospital

uemura_h@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026