A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

Launched by CHEMO MOUTHPIECE · Oct 14, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-80 years
• 2. Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
• • CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU)
• • Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), 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 (excluding FOLFOX)
• • 3. Be willing and able to complete all study-related activities
• • 4. Properly obtained written informed consent
• Exclusion Criteria:
• • 1. Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
• • 2. Concurrent radiotherapy
• • 3. Unable or unwilling to complete study assessments
• • 4. Unable or unwilling to avoid using ice chips
• • 5. Known allergy to silicone
• • 6. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
• • 7. 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
• • 8. Chronic use of opioid analgesics