Clinical study of the preventive effect of Nobelzin on the development of severe oral mucositis during radiation chemotherapy in oral cancer

Phase 1

Recruiting

• Conditions: Oral cancer

• Registration Number: JPRN-jRCTs061230046
• Lead Sponsor: Yanamoto Souichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age: 18 to 90 years of age at the time of consent
2. Patients who have obtained written consent from the individual or a proxy who is deemed able to represent the individual's wishes and interests.
3. Patients with stage 2 or higher oral cancer who are scheduled to receive radiation chemotherapy (chemotherapy should be cisplatin or cetuximab)
4. Patients with serum zinc concentration below the reference level (80 microgram/dL)
5. Patients without oral mucositis at 2 weeks prior to the start of radiation chemotherapy

Exclusion Criteria

1. Patients who are allergic or hypersensitive to any of the drugs in this study
2. Patients who are using concomitant medications that should not be used in combination with the drugs in this study
3. Patients who have difficulty in receiving cisplatin 80 mg/m2 in the case of cisplatin administration
4. Patients who are judged by the investigator to be inappropriate as research subjects
5. Patients participating in other clinical studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified