Oral MucositisNCT04595838
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
A study testing Chemo Mouthpiece in people with Oral Mucositis, run by Chemo Mouthpiece at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Chemo Mouthpiece
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Aug 2020to 18 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Any other 5-FU-based regimen (excluding FOLFOX)
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Erie County Medical Center
Buffalo, New York, 14215
The Christ Hospital
Cincinnati, Ohio, 45219
Chan Soon-Shiong Institute for Medicine
Costa Mesa, California, 92627
Revive Research Institute
Farmington Hills, Michigan, 48334
Goshen Health
Goshen, Indiana, 46526
Inspira Medical Center
Mullica Hill, New Jersey, 08062
New York Cancer & Blood Specialists
New York, New York, 11776
Phelps Health
Rolla, Missouri, 65401
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Revive Research Institute, Inc.
Sterling Heights, Michigan, 48314
Inspira Medical Center
Vineland, New Jersey, 08360
About this study
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
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
- Being tested
- Chemo Mouthpiece, Best Supportive Care only
- Keywords
- Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo MouthpieceDevice
Also called Oral cryotherapy delivery device
Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
Best Supportive Care onlyOther
Standard Oral care for Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Best supportive oral care and Chemo Mouthpiece | Experimental | Patients will receive best supportive oral care along with using the Chemo Mouthpiece device. Receives: Device: Chemo Mouthpiece |
| Arm B Best supportive oral care only | Other | Patients will receive best supportive oral care only. Receives: Other: Best Supportive Care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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.
Measured: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Incidence and severity of oral mucositis symptoms per chemotherapy cycle
- 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.
Measured: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Duration of oral mucositis symptoms
- 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.
Measured: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Duration of oral mucositis symptoms
- 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.
Measured: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Percent of days the Chemo MouthpieceTM was used
- 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.
Measured: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Percent of days the Chemo MouthpieceTM was used
- 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.
Measured: 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
patient-reported Chemo Mouthpiece End of Study Device Assessment
Measured: 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
patient-reported Chemo Mouthpiece End of Study Device Assessment
Measured: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Analgesic use to control mouth pain
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.
Measured: Cycle 1 of chemotherapy (14-28 days, time frame varies based on regimen)
Analgesic use to control mouth pain
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.
Measured: Cycle 2 of chemotherapy (14-28 days, time frame varies based on regimen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start31 Aug 2020
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemo Mouthpiece
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Jacobucci, Study director, Chemo Mouthpiece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595838
- Sponsor's protocol ID
- CHEM-01
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40742459
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04595838
- Acronym / sponsor ID
- CHEM-01
- Conditions
- Oral Mucositis
- Keywords
- Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Chemo MouthpieceIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Best supportive oral care and Chemo Mouthpiece | Experimental | Device: Chemo MouthpiecePatients will receive best supportive oral care along with using the Chemo Mouthpiece device. |
| Arm B Best supportive oral care only | Other | Other: Best Supportive Care onlyPatients will receive best supportive oral care only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-80 years
- Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as:
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemo MouthpieceAlso: Oral cryotherapy delivery deviceFrozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis | Device | Arm A:Best supportive oral care and Chemo Mouthpiece |
| Best Supportive Care onlyStandard Oral care for Chemotherapy | Other | Arm B Best supportive oral care only |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
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)
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)
Duration of oral mucositis symptoms
Time frame: 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)
Percent of days the Chemo MouthpieceTM was used
Time frame: 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)
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)
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)
Analgesic use to control mouth pain
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 40742459Zuniga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Jacobucci study director
Chemo Mouthpiece
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemo Mouthpiece in people with Oral Mucositis, run by Chemo Mouthpiece at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.