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

JRCT ID: jRCTs061230046

Registered date:10/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral cancer
• Date of first enrollment: 10/08/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The initial dose of zinc acetate hydrate (NOBELZIN) is 50 mg twice daily (100 mg/day) for 1 week prior to the start of radiotherapy, and 50 mg three times daily (150 mg/day) for 6 weeks during the radiotherapy period, for a total of 7 weeks.

Outcome(s)

• Primary Outcome: The highest oral mucositis Grade value observed during radiation chemotherapy (CTCAE v4.0) will be used to compare the incidence of Grade 3 or higher oral mucositis with historical data.

Secondary Outcome

1. The completion rate of radiation chemotherapy (the number of patients who were able to complete the planned dose of radiation and chemotherapy/total number of patients) will be compared with historical data reported in the past.
2. Patients will be divided into two groups: a low serum zinc group (patients with serum zinc concentration of less than 80 microgram/dL at the end of radiation chemotherapy) and a normal serum zinc group (patients with serum zinc concentration of 80 microgram/dL or higher at the end of radiation chemotherapy) to determine whether there is a significant difference in oral mucositis Grade values between the two groups.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yanamoto Souichi
• Source(s) of Monetary Support: Nobelpharma Co., Ltd.