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

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

This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.

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