Oral Mucositis
Conditions
Keywords
Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
Brief summary
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.
Interventions
OTHERBest Supportive Care only
Standard Oral care for Chemotherapy
DEVICEChemo Mouthpiece
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
Sponsors
Chemo Mouthpiece
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
| The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) | The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
| The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
| The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) | The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of days the Chemo MouthpieceTM was used | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | • Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device. |
| Analgesic use to control mouth pain | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | Device use will be measured on a daily diary completed for at least the first 14 days of each cycle. The diary will also be completed on any additional days that the patient uses the device. |
| Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | patient-reported Chemo Mouthpiece End of Study Device Assessment |
| Incidence and severity of oral mucositis symptoms per chemotherapy cycle | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
| Duration of oral mucositis symptoms | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) | • The presence and severity of oral mucositis symptoms will be measured by patient self-report using the Oral Mucositis Symptom Assessment scale with positive symptoms defined as a score of 1 or greater and severe symptoms defined as a score of 2 or greater. |
Countries
United States
Outcome results
None listed