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

September 15, 2023 updated by: Chemo Mouthpiece

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of oral mucositis symptomatic events observed during the first cycle of chemotherapy.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of oral mucositis symptoms per chemotherapy cycle
Time Frame: 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.
Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Incidence and severity of oral mucositis symptoms per chemotherapy cycle
Time Frame: 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.
Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Duration of oral mucositis symptoms
Time Frame: 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.
Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Duration of oral mucositis symptoms
Time Frame: 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.
Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Percent of days the Chemo MouthpieceTM was used
Time Frame: Cycle 1 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.
Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Percent of days the Chemo MouthpieceTM was used
Time Frame: 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.
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
Time Frame: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
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
Time Frame: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
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
Time Frame: Cycle 1 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.
Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Analgesic use to control mouth pain
Time Frame: 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.
Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chemo Mouthpiece

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Frank Jacobucci, Chemo Mouthpiece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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