Exploration of Improving Treatment Outcomes for Gastrointestinal Malignant Tumors by Targeting Oral Environment and Oral Frailty

JRCT ID: jRCT1030240573

Registered date:20/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastrointestinal malignant tumors
• Date of first enrollment: 13/11/2024
• Target sample size: 600
• Study type: Interventional

Intervention(s)

Masticatory Ability Measurement: Using xylitol chewing check gum.
Data Measurement: Using a body composition analyzer.

Outcome(s)

Primary Outcome

Correlation Between Oral Findings and Treatment Outcomes in Patients with Gastrointestinal Malignancies
Correlation of Sarcopenia and Frailty with Masticatory Ability and Oral Frailty Findings in Patients with Malignant Tumors

• Secondary Outcome: Relationship with Occlusal Muscles and Muscle Mass

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

Inclusion Criteria for Consent Procedure
The following conditions (1 to 3) must all be met
1.Age Requirement: Individuals aged 20 years or older at the time of obtaining consent.
2.Diagnosis: Patients diagnosed with gastrointestinal malignant tumors (e.g. esophageal cancer, gastric cancer, colorectal cancer, sarcoma, malignant lymphoma, etc.).
3.Informed Consent: Individuals who, after receiving sufficient explanation regarding participation in this study, fully understand the details and provide written consent of their own free will.

Opt-Out Research Subjects
Individuals who have not expressed a refusal to participate in this study through the information disclosure documents.

Exclude criteria

Exclusion Criteria
Individuals who meet any of the following conditions:
1.Difficulty Chewing Xylitol Gum: Individuals who find it difficult to chew xylitol-containing gum in their daily lives.
2.Refusal to Participate: Individuals who have explicitly expressed refusal to participate in this study through the information disclosure documents.
3.Other Reasons: Patients deemed unsuitable for participation by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Matsubara Hisahiro