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

NCT04595838 | Completed FDA Device

• 1 other identifier: CHEM-01
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 11

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.

Conditions

Oral Mucositis

Keywords

Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Incidence and severity of oral mucositis symptoms per chemotherapy cycle

  Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

• Incidence and severity of oral mucositis symptoms per chemotherapy cycle

  Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

• Duration of oral mucositis symptoms

  Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

• Duration of oral mucositis symptoms

  Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)

• Percent of days the Chemo MouthpieceTM was used

  Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)

Study Arms (2)

Arm A:Best supportive oral care and Chemo Mouthpiece

EXPERIMENTAL

Patients will receive best supportive oral care along with using the Chemo Mouthpiece device.

Device: Chemo Mouthpiece

Arm B Best supportive oral care only

OTHER

Patients will receive best supportive oral care only.

Other: Best Supportive Care only

Interventions

Chemo Mouthpiece DEVICE

Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis

Also known as: Oral cryotherapy delivery device

Arm A:Best supportive oral care and Chemo Mouthpiece

Best Supportive Care only OTHER

Standard Oral care for Chemotherapy

Arm B Best supportive oral care only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years
• 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)
• Be willing and able to complete all study-related activities
• Properly obtained written informed consent

You may not qualify if:

• Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
• Concurrent radiotherapy
• Unable or unwilling to complete study assessments
• Unable or unwilling to avoid using ice chips
• Known allergy to silicone
• Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization
• 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
• Chronic use of opioid analgesics

Sponsors & Collaborators

• Chemo Mouthpiece: lead

Study Sites (11)

Chan Soon-Shiong Institute for Medicine

Costa Mesa, California, 92627, United States

Location

Goshen Health

Goshen, Indiana, 46526, United States

Location

Revive Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Revive Research Institute, Inc.

Sterling Heights, Michigan, 48314, United States

Location

Phelps Health

Rolla, Missouri, 65401, United States

Location

Inspira Medical Center

Mullica Hill, New Jersey, 08062, United States

Location

Inspira Medical Center

Vineland, New Jersey, 08360, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

New York Cancer & Blood Specialists

New York, New York, 11776, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

• Zuniga R, Dembla V, Alam N, Nangia C, Guerrero-Garcia T, Chung G, Kio E, Go M, Tubb E, Sonis S, Jacobucci F. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device. Support Care Cancer. 2025 Jul 31;33(8):732. doi: 10.1007/s00520-025-09795-x.

  PMID: 40742459 DERIVED

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Frank Jacobucci

  Chemo Mouthpiece

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: August 31, 2020
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)