OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis (OZOCLO_MUCOS)
Mucositis (MeSH Unique ID: D052016), Stomatitis (MeSH Unique ID: D013280)
About this trial
This is an interventional prevention trial for Mucositis (MeSH Unique ID: D052016)
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Group I, OZOCLO
Group II, OBC
Group III, CHX
Group IV, AAL-OZ
• Group I, OZOCLO alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks
• Group II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 3 weeks
• Group III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks
• Group IV, AAL-OZ alpha acid lipoic - 600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days ozonated oil - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 2 weeks