Back to resultsA Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemo Mouthpiece
Best Supportive Care only
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
Eligibility Criteria
Inclusion Criteria:
- Aged 18-80 years
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)
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Exclusion Criteria:
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Unable or unwilling to avoid using ice chips
- Known allergy to silicone
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
- 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
- Chronic use of opioid analgesics
Sites / Locations
- Chan Soon-Shiong Institute for Medicine
- Goshen Health
- Revive Research Institute
- Revive Research Institute, Inc.
- Phelps Health
- Inspira Medical Center
- Inspira Medical Center
- Erie County Medical Center
- New York Cancer & Blood Specialists
- The Christ Hospital
- Gibbs Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm A:Best supportive oral care and Chemo Mouthpiece
Arm B Best supportive oral care only
Arm Description
Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.
Patients will receive best supportive oral care only.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04595838
Brief Title
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
Official Title
A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemo Mouthpiece
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A:Best supportive oral care and Chemo Mouthpiece
Arm Type
Experimental
Arm Description
Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.
Arm Title
Arm B Best supportive oral care only
Arm Type
Other
Arm Description
Patients will receive best supportive oral care only.
Intervention Type
Device
Intervention Name(s)
Chemo Mouthpiece
Other Intervention Name(s)
Oral cryotherapy delivery device
Intervention Description
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
Intervention Type
Other
Intervention Name(s)
Best Supportive Care only
Intervention Description
Standard Oral care for Chemotherapy
Primary Outcome Measure Information:
Title
The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
Description
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)
Title
The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy.
Description
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)
Title
The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy.
Description
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)
Title
The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy.
Description
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)
Secondary Outcome Measure Information:
Title
Incidence and severity of oral mucositis symptoms per chemotherapy cycle
Description
• 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)
Title
Incidence and severity of oral mucositis symptoms per chemotherapy cycle
Description
• 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)
Title
Duration of oral mucositis symptoms
Description
• 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)
Title
Duration of oral mucositis symptoms
Description
• 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)
Title
Percent of days the Chemo MouthpieceTM was used
Description
• 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)
Title
Percent of days the Chemo MouthpieceTM was used
Description
• 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)
Title
Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment
Description
patient-reported Chemo Mouthpiece End of Study Device Assessment
Time Frame
Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Title
Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment
Description
patient-reported Chemo Mouthpiece End of Study Device Assessment
Time Frame
Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Title
Analgesic use to control mouth pain
Description
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)
Title
Analgesic use to control mouth pain
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-80 years
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)
Be willing and able to complete all study-related activities
Properly obtained written informed consent
Exclusion Criteria:
Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
Concurrent radiotherapy
Unable or unwilling to complete study assessments
Unable or unwilling to avoid using ice chips
Known allergy to silicone
Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
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
Chronic use of opioid analgesics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Jacobucci
Organizational Affiliation
Chemo Mouthpiece
Official's Role
Study Director
Facility Information:
Facility Name
Chan Soon-Shiong Institute for Medicine
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Goshen Health
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Revive Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Revive Research Institute, Inc.
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Phelps Health
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Inspira Medical Center
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
08062
Country
United States
Facility Name
Inspira Medical Center
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
New York Cancer & Blood Specialists
City
New York
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
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