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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595838
• Other study ID #: CHEM-01
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: May 18, 2023

Study information

• Verified date: September 2023
• Source: Chemo Mouthpiece
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Chemo Mouthpiece
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis

Other:
• Best Supportive Care only
Standard Oral care for Chemotherapy

Locations

Country	Name	City	State
United States	Erie County Medical Center	Buffalo	New York
United States	The Christ Hospital	Cincinnati	Ohio
United States	Chan Soon-Shiong Institute for Medicine	Costa Mesa	California
United States	Revive Research Institute	Farmington Hills	Michigan
United States	Goshen Health	Goshen	Indiana
United States	Inspira Medical Center	Mullica Hill	New Jersey
United States	New York Cancer & Blood Specialists	New York	New York
United States	Phelps Health	Rolla	Missouri
United States	Gibbs Cancer Center	Spartanburg	South Carolina
United States	Revive Research Institute, Inc.	Sterling Heights	Michigan
United States	Inspira Medical Center	Vineland	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Chemo Mouthpiece

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)