Clinical trial NCT04595838: 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
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
Lead sponsor: Chemo Mouthpiece
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: The incidence of oral mucositis symptomatic events observed during the second cycle of chemotherapy.
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: The incidence of severe oral mucositis symptomatic events observed during the first cycle of chemotherapy.
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: The incidence of severe oral mucositis symptomatic events observed during the second cycle of chemotherapy.
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Secondary outcomes:
measure: Incidence and severity of oral mucositis symptoms per chemotherapy cycle
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Incidence and severity of oral mucositis symptoms per chemotherapy cycle
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Duration of oral mucositis symptoms
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Duration of oral mucositis symptoms
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Percent of days the Chemo MouthpieceTM was used
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Percent of days the Chemo MouthpieceTM was used
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Ease of use of the Chemo MouthpieceTM based on patient-reported Chemo Mouthpiece End of Study Device Assessment
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Analgesic use to control mouth pain
timeFrame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
measure: Analgesic use to control mouth pain
timeFrame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Chan Soon-Shiong Institute for Medicine
state: California
city: Goshen
country: United States
facility: Goshen Health
state: Indiana
city: Farmington Hills
country: United States
facility: Revive Research Institute
state: Michigan
city: Sterling Heights
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Rolla
country: United States
facility: Phelps Health
state: Missouri
city: Mullica Hill
country: United States
facility: Inspira Medical Center
state: New Jersey
city: Vineland
country: United States
facility: Inspira Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: New York Cancer & Blood Specialists
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Spartanburg
country: United States
facility: Gibbs Cancer Center
state: South Carolina
Study officials:
affiliation: Chemo Mouthpiece
name: Frank Jacobucci
role: STUDY_DIRECTOR
References: