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Analysis of the Effects of Preoperative Mouthwash Intervention on the Microbiome,Tumor Immune Environment,and Prognosis in Oral Cancer

Analysis of the Effects of Preoperative Mouthwash Intervention on the Microbiome,Tumor Immune Environment,and Prognosis in Oral Cancer

Uzawa Narikazu

Graduate School of Dentistry, Osaka University, Osaka, Japan

1-8 Yamadaoka, Suita, Osaka 565-0871, Japan

uzawa.narikazu.dent@osaka-u.ac.jp

Uzawa Narikazu

Graduate School of Dentistry, Osaka University

1-8 Yamadaoka, Suita, Osaka 565-0871, Japan

+81-6-6879-2941

uzawa.narikazu.dent@osaka-u.ac.jp

Recruiting

Feb. 27, 2026

Interventional

single arm study

open(masking not used)

historical control

single assignment

other

1.Age 18 years or older at the time of consent.
2.Ability to tolerate oral intake.
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, defined as follows:
0: Fully active, able to carry on all pre-disease activities without restriction.
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
4.Provision of written informed consent by the participant after receiving a full explanation of the study.

1.Presence of an active infection requiring systemic treatment.
2.Women who are pregnant, potentially pregnant, or breastfeeding.
3.Presence of psychiatric disorders or psychiatric symptoms that, in the opinion of the investigator, would interfere with participation in the study.
4.Evidence of active bleeding.
5.Ongoing systemic corticosteroid therapy or treatment with immunosuppressive agents.
6.Use of systemic antibiotics within 1 week prior to surgery (in principle).
7.Participation in another interventional clinical study.
8.Any other condition that, in the judgment of the principal investigator or sub-investigator, renders the participant unsuitable for the study.

Both

Oral Cancer

Patients with oral cancer scheduled to undergo curative surgery at our department will be enrolled in this study. Participants will be instructed to use a mouthwash continuously during the preoperative period.

At the time of surgery, bacterial samples will be collected from both tumor tissue and adjacent normal mucosa. In addition, fecal samples will be obtained. The collected specimens will be subjected to microbiome analysis.

Furthermore, fresh tumor tissue obtained during surgery will be used for immunophenotyping by flow cytometry to characterize the local tumor immune microenvironment.

C07

Analysis of the oral and gut microbiota
Characterization of tumor-infiltrating immune cells

+81-6-6210-8270

Oct. 17, 2025

No

none