An interventional study of Chemo Mouthpiece and Best Supportive Care only in Oral Mucositis, sponsored by Chemo Mouthpiece. Completed at 11 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Chemo Mouthpiece · Not applicable, Interventional, and Supportive care
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 176 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →This is the only study on the registry with Chemo Mouthpiece as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
Exclusion Criteria:
Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.
Device: Chemo Mouthpiece
Patients will receive best supportive oral care only.
Other: Best Supportive Care only
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
Also known as: Oral cryotherapy delivery device
Standard Oral care for Chemotherapy
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)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.