A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Other: Best Supportive Care only; Device: Chemo Mouthpiece

• Registration Number: NCT04595838
• Lead Sponsor: Chemo Mouthpiece

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-31
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-22
• Primary Completion: 2023-05-18
• Study Completion: 2023-05-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. Aged 18-80 years

2. 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)

3. Be willing and able to complete all study-related activities

4. Properly obtained written informed consent

Exclusion Criteria

1. Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
2. Concurrent radiotherapy
3. Unable or unwilling to complete study assessments
4. Unable or unwilling to avoid using ice chips
5. Known allergy to silicone
6. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
7. 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
8. Chronic use of opioid analgesics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B Best supportive oral care only	Best Supportive Care only	Patients will receive best supportive oral care only.
Arm A:Best supportive oral care and Chemo Mouthpiece	Chemo Mouthpiece	Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.

Primary Outcome Measures

Name	Time	Method
The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.	Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)	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.	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	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.	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	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.	Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)	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

Name	Time	Method
Incidence and severity of oral mucositis symptoms per chemotherapy cycle	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	• 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	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	• 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	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	• 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	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	patient-reported Chemo Mouthpiece End of Study Device Assessment
Analgesic use to control mouth pain	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)	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.

Trial Locations

Locations (10)

Chan Soon-Shiong Institute for Medicine; 🇺🇸 Costa Mesa, California, United States

Phelps Health; 🇺🇸 Rolla, Missouri, United States

Gibbs Cancer Center; 🇺🇸 Spartanburg, South Carolina, 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

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

Inspira Medical Center; 🇺🇸 Vineland, New Jersey, United States