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

JRCT ID: jRCTs061230081

Registered date:18/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: perioperative gastric cancer patients with presbyphagia
• Date of first enrollment: 18/12/2023
• Target sample size: 42
• Study type: Interventional
• Intervention(s): swallowing excercise used by tantore sheet

Outcome(s)

• Primary Outcome: Comparison of the change in maximum tongue pressure from baseline at the 4 week of intervention

Secondary Outcome

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) Change in EAT-10 from baseline at the 4 week of intervention
(8) Continuation rate of training
(9) Number and frequency of adverse events

For both the tantore sheet group and the control group:
(10) Comparison of maximum tongue pressure values at baseline, 2 weeks, and 4 weeks of intervention
(11) Comparison of vertical cross-sectional area of the geniohyoid muscle at baseline, 2 weeks, and 4 weeks of intervention
(12) Comparison of pharyngeal residue after swallowing at baseline and 4 weeks of intervention
(13) Comparison of PAS at baseline and 4 weeks of intervention
(14) Comparison of EAT-10 at baseline and 4 weeks of intervention

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) 65 years or older
(2) Maximum tongue pressure of less than 30kPa
(3) EAT-10 Japanese version score of 3 or higher
(4) FOIS(Functional oral intake scale) of 5 or higher
(5) Received standard swallowing rehabilitation before gastric cancer surgery
(6) Consent for the research has been obtained from the participant

Exclude 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) of less than 160L/min
(7) The participatiant deemed inappropriate as research subjects by the principal investigator or co-investigat

Related Information

• Primary Sponsor: Yamamoto Sayako
• Source(s) of Monetary Support: tantore Co., Ltd,tantore Co., Ltd