Oral cancer
Conditions
Interventions
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 rad
Sponsors
Yanamoto Souichi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactYamasaki Sachiko
Hiroshima University Hospital
Outcome results
None listed