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

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

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 Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: Chemo Mouthpiece; Other: Best Supportive Care only

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Jacobucci; Phone Number: 609-330-4949; Email: fjacobucci@chemomouthpiece.com
• Study Contact Backup: Name: Nick McGuire; Phone Number: 845-420-5141; Email: nmcguire@chemomouthpiece.com

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • Chan Soon-Shiong Institute for Medicine
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Health
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Revive Research Institute
    • Sterling Heights, Michigan, United States, 48314
      • Revive Research Institute, Inc.
  • Missouri
    • Rolla, Missouri, United States, 65401
      • Phelps Health
  • New Jersey
    • Mullica Hill, New Jersey, United States, 08062
      • Inspira Medical Center
    • Vineland, New Jersey, United States, 08360
      • Inspira Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • New York, New York, United States, 11776
      • New York Cancer & Blood Specialists
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm B Best supportive oral care only; Patients will receive best supportive oral care only.	Other: Best Supportive Care only; Standard Oral care for Chemotherapy
Experimental: Arm A:Best supportive oral care and Chemo Mouthpiece; Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.	Device: Chemo Mouthpiece; Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis; Other Names: Oral cryotherapy delivery device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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	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.	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.	Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

Collaborators and Investigators

• Sponsor: Chemo Mouthpiece
• Investigators: Study Director: Frank Jacobucci, Chemo Mouthpiece

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: CHEM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes