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Clinical Trials/JPRN-jRCTs061230046
JPRN-jRCTs061230046
Recruiting
Phase 1

An exploratory single-arm study of the preventive effect of Nobelzin on the development of severe oral mucositis during radiation chemotherapy in oral cancer

Yanamoto Souichi0 sites20 target enrollmentAugust 10, 2023
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Yanamoto Souichi
Enrollment
20
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 10, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Yanamoto Souichi

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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