Status:
UNKNOWN
OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis
Lead Sponsor:
University of Palermo
Conditions:
Mucositis (MeSH Unique ID: D052016)
Stomatitis (MeSH Unique ID: D013280)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM). It is the ulcerative phase that is most painful and associated wit...
Detailed Description
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM) begins in the submucosa and becomes clinically on the surface about...
Eligibility Criteria
Inclusion
- Aged 18-80 years
- Planned to receive conventional chemotherapy such as:
- CMF (cyclophosphamide (Endoxan), methotrexate, 5-FU))
- Standard AC+T regimen (doxorubicin (Adriamycin)), cyclophosphamide (Endoxan), Taxane \[paclitaxel (Taxol) or docetaxel (Taxotere)) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
- ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
- FOLFIRI (irinotecan, 5-FU, leucovorin)
- Any other 5-FU-based regimen
- Planned to receive at conventional new generation targeted agents (tyrosine-kinase inhibitors or monoclonal antibodies) such as cetuximab, axitinib, bevacizumab, sunitinib, and sorafenib, temsirolimus, everolimus, vemurafenib, dabrafenib.
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Exclusion
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days before randomization
- Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
- Chronic use of opioid analgesics
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05211622
Start Date
March 10 2022
End Date
January 10 2023
Last Update
January 27 2022
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