A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
Public ClinicalTrials.gov record NCT04595838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04595838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 176 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2020
- Primary completion
- May 17, 2023
- Completion
- May 17, 2023
- Last update posted
- Sep 17, 2023
2020 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chan Soon-Shiong Institute for Medicine | Costa Mesa | California | 92627 | — |
| Goshen Health | Goshen | Indiana | 46526 | — |
| Revive Research Institute | Farmington Hills | Michigan | 48334 | — |
| Revive Research Institute, Inc. | Sterling Heights | Michigan | 48314 | — |
| Phelps Health | Rolla | Missouri | 65401 | — |
| Inspira Medical Center | Mullica Hill | New Jersey | 08062 | — |
| Inspira Medical Center | Vineland | New Jersey | 08360 | — |
| Erie County Medical Center | Buffalo | New York | 14215 | — |
| New York Cancer & Blood Specialists | New York | New York | 11776 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04595838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 17, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04595838 live on ClinicalTrials.gov.