A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer
Overview
This study will compare the use of Chemo Mouthpiece TM along with best oral supportive care to best oral supportive care only in preventing and easing symptoms of chemotherapy related oral mucositis. Patients who are receiving protocol specified chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All patients will complete daily questionnaires for the first 14 days of Cycles 1 and 2 of chemotherapy. Patients who are assigned to the study device will use the device during their chemotherapy infusion as well as at least twice a day at home for the first 7 days of Cycles 1 and 2 of chemotherapy. At the beginning of Cycle 3, patients that were not assigned to the study device will be given the option to receive study device for the remainder of their treatment.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply
- Aged 18-80 years
- 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)
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Unable or unwilling to avoid using ice chips
- Known allergy to silicone
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to 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
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
N/A
Principal Investigator
Vikas Dembla, MD
Sponsor(s)
Chemo Mouthpiece