Clinical Trial: Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum (Japan)

Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061724) titled 'Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum' on June 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Kagawa University Hospital

Condition: Condition - Esophageal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - At our hospital, we continuously evaluate "Cancer Locomotive Syndrome" (Cancer Loco) to maintain and improve ADL, QOL, physical function, oral function, and nutritional status in cancer patients. Specifically, we have observed that patients undergoing surgical treatment for esophageal cancer often require an extended period to recover their occlusal force due to postoperative dietary restrictions. This study aims to introduce "masticatory training using chewing gum" to promote chewing movements and to verify its therapeutic effect on occlusal force in these patients. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Selection and Procedures: Participants are selected during their first visit to the Cancer Locomotive Syndrome Outpatient Clinic. The study follows a pre-defined observation and examination schedule. As part of standard clinical care for cancer locomotive management, no changes to the treatment plan will be made except for the addition of gum training. Intervention Details: Timing of Initiation: After discharge from the ICU. Duration: From the initiation of training until one month postoperatively (approximately 30 days). Frequency and Dose: Chewing two pieces of gum for 5 minutes per session, twice daily. Method: This masticatory training is performed daily for 30 consecutive days. The training is integrated into the standard perioperative rehabilitation program without altering other medical interventions. Interventions/Control_2 - This group includes past cases who received standard "Cancer Locomotive Management" and routine perioperative care (early mobilization, respiratory physiotherapy, and swallowing therapy) before the introduction of the gum training. While these patients underwent standard cancer locomotive assessments and interventions, they did not perform the specific masticatory training using chewing gum (5 minutes per session, twice daily, for 30 days) defined in this study.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Inclusion Criteria: Patients aged 20 years or older. Patients with esophageal cancer scheduled for surgical treatment. Patients enrolled in the study "Physical function and QOL improvement through multidisciplinary intervention for locomotive syndrome in cancer patients" (Approval No. 2025-050). Patients evaluated by a dentist as capable of performing masticatory training using gum. Patients capable of preoperative and postoperative follow-up assessments. Patients who have provided written informed consent for participation in this study. Key exclusion criteria - Participants meeting any of the following criteria will be excluded: Patients with significant cognitive decline, persistent delirium, or psychiatric disorders that make it difficult to understand study procedures or complete assessments. Patients for whom the continuation of gum training or rehabilitation therapy is difficult due to severe postoperative complications or comorbidities. Patients with dental conditions (e.g., severe tooth loss or significant oral pain) that prevent safe gum chewing. Patients otherwise judged as inappropriate for participation by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 05 Month 27 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069966

Disclaimer: Curated by HT Syndication.