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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Best supportive oral care and Chemo Mouthpiece | Experimental | Patients will receive best supportive oral care along with using the Chemo Mouthpiece device. |
|
| Arm B Best supportive oral care only | Other | Patients will receive best supportive oral care only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemo Mouthpiece | Device | Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy. | 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy. | 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy. | 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy. | 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of oral mucositis symptoms per chemotherapy cycle | • 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
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Inclusion Criteria:
Aged 18-80 years
Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
Be willing and able to complete all study-related activities
Properly obtained written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Jacobucci | Chemo Mouthpiece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chan Soon-Shiong Institute for Medicine | Costa Mesa | California | 92627 | United States | ||
| Goshen Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40742459 | Derived | Zuniga R, Dembla V, Alam N, Nangia C, Guerrero-Garcia T, Chung G, Kio E, Go M, Tubb E, Sonis S, Jacobucci F. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device. Support Care Cancer. 2025 Jul 31;33(8):732. doi: 10.1007/s00520-025-09795-x. |
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|
| Best Supportive Care only | Other | Standard Oral care for Chemotherapy |
|
| Incidence and severity of oral mucositis symptoms per chemotherapy cycle | • 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Duration of oral mucositis symptoms | • 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Duration of oral mucositis symptoms | • 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Percent of days the Chemo MouthpieceTM was used | • 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Percent of days the Chemo MouthpieceTM was used | • 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment | patient-reported Chemo Mouthpiece End of Study Device Assessment | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment | patient-reported Chemo Mouthpiece End of Study Device Assessment | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Analgesic use to control mouth pain | 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. | Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Analgesic use to control mouth pain | 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. | Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) |
| Goshen |
| Indiana |
| 46526 |
| United States |
| Revive Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Revive Research Institute, Inc. | Sterling Heights | Michigan | 48314 | United States |
| Phelps Health | Rolla | Missouri | 65401 | United States |
| Inspira Medical Center | Mullica Hill | New Jersey | 08062 | United States |
| Inspira Medical Center | Vineland | New Jersey | 08360 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| New York Cancer & Blood Specialists | New York | New York | 11776 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | United States |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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