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

NCT ID: NCT04595838

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2023-05-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A:Best supportive oral care and Chemo Mouthpiece

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

Group Type: EXPERIMENTAL

Chemo Mouthpiece

Intervention Type: DEVICE

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

Arm B Best supportive oral care only

Patients will receive best supportive oral care only.

Group Type: OTHER

Best Supportive Care only

Intervention Type: OTHER

Standard Oral care for Chemotherapy

Interventions

Chemo Mouthpiece

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

Intervention Type: DEVICE

Best Supportive Care only

Standard Oral care for Chemotherapy

Intervention Type: OTHER

Other Intervention Names

Oral cryotherapy delivery device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chemo Mouthpiece

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Jacobucci

Role: STUDY_DIRECTOR

Chemo Mouthpiece

Locations

Chan Soon-Shiong Institute for Medicine

Costa Mesa, California, United States

Goshen Health

Goshen, Indiana, United States

Revive Research Institute

Farmington Hills, Michigan, United States

Revive Research Institute, Inc.

Sterling Heights, Michigan, United States

Phelps Health

Rolla, Missouri, United States

Inspira Medical Center

Mullica Hill, New Jersey, United States

Inspira Medical Center

Vineland, New Jersey, United States

Erie County Medical Center

Buffalo, New York, United States

New York Cancer & Blood Specialists

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Gibbs Cancer Center

Spartanburg, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40742459 (View on PubMed)

Other Identifiers

CHEM-01

Identifier Type: -

Identifier Source: org_study_id