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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
176
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
Standard Oral care for Chemotherapy
Chan Soon-Shiong Institute for Medicine
Costa Mesa, California, United States
Goshen Health
Goshen, Indiana, United States
Revive Research Institute
Farmington Hills, Michigan, United States
Revive Research Institute, Inc.
Sterling Heights, Michigan, United States
Phelps Health
Rolla, Missouri, United States
Inspira Medical Center
Mullica Hill, New Jersey, United States
Inspira Medical Center
Vineland, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
New York Cancer & Blood Specialists
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
...and 1 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
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.
Time frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
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