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A Trial Testing Chemo Mouthpiece Device and Best Supportive Care Against Best Supportive Care Only for Symptoms of Oral Mucositis in Patients Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04595838
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Chemo Mouthpiece

Study Description
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Brief Summary:
This study will compare the use of Chemo Mouthpiece TM along with best oral supportive care to best oral supportive care only in preventing and easing symptoms of chemotherapy related oral mucositis. Patients who are receiving protocol specified chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All patients will complete daily questionnaires for the first 14 days of Cycles 1 and 2 of chemotherapy. Patients who are assigned to the study device will use the device during their chemotherapy infusion as well as at least twice a day at home for the first 7 days of Cycles 1 and 2 of chemotherapy. At the beginning of Cycle 3, patients that were not assigned to the study device will be given the option to receive study device for the remainder of their treatment.

Condition or disease Intervention/treatment Phase
Oral Mucositis Device: Chemo Mouthpiece Other: Best Supportive Care only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
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 Name: Oral cryotherapy delivery device
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595838


Contacts
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Contact: Frank Jacobucci 609-330-4949 fjacobucci@chemomouthpiece.com
Contact: Nick McGuire 845-420-5141 nmcguire@chemomouthpiece.com

Locations
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United States, California
Chan Soon-Shiong Institute for Medicine Not yet recruiting
Costa Mesa, California, United States, 92627
Contact: Atessa Kiani    949-764-6586    atessa.kiani@hoag.org   
Principal Investigator: Chaitali Nangia, MD         
United States, Indiana
Goshen Health Recruiting
Goshen, Indiana, United States, 46526
Contact: Jillian Borsa    574-364-2649    jborsa2@goshenhealth.com   
Principal Investigator: Ebenezer Kio, MD         
United States, Missouri
Phelps Health Not yet recruiting
Rolla, Missouri, United States, 65401
Contact: Katy McMillian    573-458-7504    kmcmillian@phelpshealth.org   
Principal Investigator: Thomas Guerrero-Garcia, MD         
United States, New York
Erie County Medical Center Not yet recruiting
Buffalo, New York, United States, 14215
Contact: James Zemer    585-943-6551    jzemer@ecmc.edu   
Principal Investigator: Carly Gerretsen, DNP         
New York Cancer & Blood Specialists Recruiting
New York, New York, United States, 11776
Contact: April Cintron    631-675-5269    acintron@nycancer.com   
Principal Investigator: Zulfiqar Malik, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Lisa Woeste    513-585-0844    lisa.woeste@thechristhospital.com   
Principal Investigator: Gina Chung, MD         
United States, South Carolina
Gibbs Cancer Center Not yet recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Luann Lester    864-560-1045    llester@gibbscc.org   
Principal Investigator: Vikas Dembla, MD         
Sponsors and Collaborators
Chemo Mouthpiece
Investigators
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Study Director: Frank Jacobucci Chemo Mouthpiece
More Information
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Responsible Party: Chemo Mouthpiece
ClinicalTrials.gov Identifier: NCT04595838    
Other Study ID Numbers: CHEM-01
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases