ELEVATE study

JRCT ID: jRCTs052220011

Registered date:22/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: oropharynx cancer or hypopharynx cancer
• Date of first enrollment: 22/04/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

tongue pressure mesurement
Swallowing rehabilitation

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Uemura Hirokazu
• Secondary Sponsor: JMS
• Source(s) of Monetary Support: Nara medical university