Change in tongue pressure and safety of tantore sheet for perioperative gastric cancer patients

Change in tongue pressure and safety of tantore sheet for perioperative gastric cancer patients with presbyphagia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061230081

Enrollment

Registered

2023-12-18

Start date

2024-02-29

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

perioperative gastric cancer patients with presbyphagia

Interventions

swallowing excercise used by tantore sheet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 65 years or older (2) Maximum tongue pressure of less than 30kPa (3) FOIS(Functional oral intake scale) of 5 or higher (4) Received standard swallowing rehabilitation before gastric cancer surgery (5) Consent for the research has been obtained from the participant

Exclusion criteria

Exclusion criteria: (1) Cognitive impairment (MMSE of less than 20 points) (2) Tumor lesions and inflammatory diseases in the oral cavity (tongue, gums, oral mucosa, etc.) (3) Surgical history due to malignant tumors of the oral and pharyngeal region (4) Palatal torus (5) Less than 6 months of the onset of cerebrovascular disease, head injury, or neuromuscular disease (6) CPF (Cough Peak Flow) or PF(Peak Flow) of less than 160L/min (7) The participatiant deemed inappropriate as research subjects by the principal investigator or co-investigat

Design outcomes

Primary

Measure	Time frame
Comparison of the change in maximum tongue pressure from baseline at the 4 week of intervention	—

Secondary

Measure	Time frame
Comparison between the tantore sheet group and the control group for : (1) Change in maximum tongue pressure from baseline at the 4 week of intervention (2) Number of participatiants with maximum tongue pressure exceeding 30 kPa at the 4 week of intervention(3) Change in pharyngeal residue after swallowing from baseline at the 4 week of intervention (4) Change in pharyngeal residue after swallowing from baseline at the 4 week of intervention (5) Change in PAS at the 4 week of intervention (6) Change in the vertical cross-sectional area of the geniohyoid muscle from baseline at the 4 week of intervention (7) Continuation rate of training (8) Number and frequency of adverse events For both the tantore sheet group and the control group: (9) Comparison of maximum tongue pressure values at baseline, 2 weeks, and 4 weeks of intervention (10) Comparison of vertical cross-sectional area of the geniohyoid muscle at baseline, 2 weeks, and 4 weeks of intervention (11) Comparison of pharyngeal residue after swallowing at baseline and 4 weeks of intervention (12) Comparison of PAS at baseline and 4 weeks of intervention	—

Measure

Time frame

Comparison between the tantore sheet group and the control group for : (1) Change in maximum tongue pressure from baseline at the 4 week of intervention (2) Number of participatiants with maximum tongue pressure exceeding 30 kPa at the 4 week of intervention(3) Change in pharyngeal residue after swallowing from baseline at the 4 week of intervention (4) Change in pharyngeal residue after swallowing from baseline at the 4 week of intervention (5) Change in PAS at the 4 week of intervention (6) Change in the vertical cross-sectional area of the geniohyoid muscle from baseline at the 4 week of intervention (7) Continuation rate of training (8) Number and frequency of adverse events For both the tantore sheet group and the control group: (9) Comparison of maximum tongue pressure values at baseline, 2 weeks, and 4 weeks of intervention (10) Comparison of vertical cross-sectional area of the geniohyoid muscle at baseline, 2 weeks, and 4 weeks of intervention (11) Comparison of pharyngeal residue after swallowing at baseline and 4 weeks of intervention (12) Comparison of PAS at baseline and 4 weeks of intervention

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Contacts

Public ContactSayako Yamamoto

Kawasaki Medical Shool

s-shimizu@med.kawasaki-m.ac.jp+81-864611111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026