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Behavioural Intervention

Arm B Best supportive oral care only for Mouth Sore

N/A
Waitlist Available
Research Sponsored by Chemo Mouthpiece
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Awards & highlights

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.

Eligible Conditions
  • Mouth Sore

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy.
The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy.
+1 more
Secondary outcome measures
Analgesic use to control mouth pain
Duration of oral mucositis symptoms
Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B Best supportive oral care onlyExperimental Treatment1 Intervention
Patients will receive best supportive oral care only.
Group II: Arm A:Best supportive oral care and Chemo MouthpieceExperimental Treatment1 Intervention
Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemo Mouthpiece
2020
N/A
~180

Find a Location

Who is running the clinical trial?

Chemo MouthpieceLead Sponsor
Frank JacobucciStudy DirectorChemo Mouthpiece
~35 spots leftby Sep 2025