Oral Mucositis Due to ChemotherapyPhase 4SMILENCT07287826
Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy
A Phase 4 study testing Dexamethasone Mouthwash in people with Oral Mucositis Due to Chemotherapy, run by Woman's at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are: Does using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis Due to Chemotherapy
- What is being tested?
- Dexamethasone Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Confirmed cancer diagnosis
- Scheduled to receive or receiving chemotherapy known to be associated with oral mucositis (e.g., anthracyclines and taxanes)
- Ability to provide informed consent
- Ability to comply with study procedures
Who cannot join
- Current tobacco usage or usage within the past 6 weeks.
- HIV/AIDS
- Gastrointestinal disorder (such as Crohn's disease, ulcerative colitis, or celiac disease)
- History of cold sores (herpes simplex virus)
- Herpes zoster (oral shingles) within the past 6 weeks
- Active oral infections at the time of enrollment (e.g., candidiasis)
Show all 12Show fewer
- Known sensitivity or allergy to dexamethasone
- Inability to self-administer or tolerate mouthwash protocol
- Concurrent enrollment in conflicting clinical trials
- Existing oral ulcers or oral mucositis at enrollment
- Pregnant
- Uncontrolled diabetes mellitus as defined by HbA1c unknown or >8% in the past 3 months despite adequate therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Woman's Hospital
Baton Rouge, Louisiana, 70817
Ashley R Edwards, PhD, 225-421-9185, ashley.edwards@womans.org
Ericka Seidemann, MA, 225-231-5296, ERICKA.SEIDEMANN@womans.org
About this study
Official title: Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study
The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are:
Does using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth sores?
Read more
Can this approach reduce pain and improve comfort during chemotherapy?
Researchers will compare patients using the mouthwash to a historical group of patients who received similar chemotherapy but did not use the mouthwash, to see if the mouthwash helps prevent mouth sores.
Participants will:
Use a steroid mouthwash (4 times daily) for up to 8 weeks during chemotherapy
Complete a short weekly survey about mouth discomfort during infusion visits
Read the detailed description
Oral mucositis is a common and painful side effect of chemotherapy, particularly in patients receiving regimens such as anthracyclines and taxanes. It can lead to difficulty eating, drinking, and speaking, and may result in treatment delays or dose reductions. Recent studies suggest that prophylactic use of dexamethasone mouthwash may reduce the incidence and severity of chemotherapy-induced oral mucositis. However, optimal dosing schedules and broader applicability across cancer types remain unclear.
The SMILE Study is a single-arm, prospective clinical trial designed to evaluate the effectiveness of dexamethasone mouthwash in preventing oral mucositis in adults receiving specific types of chemotherapy for cancer. Participants will be enrolled before beginning chemotherapy regimens known to be associated with a high risk of mucositis. All participants will receive dexamethasone mouthwash to use as a swish-and-spit rinse for 8 weeks.
The study will enroll at least 45 participants. Participants will be monitored throughout their chemotherapy treatment for signs and symptoms of oral mucositis, treatment adherence, and potential adverse events related to the mouthwash. Patient-reported outcomes will be collected using the Oral Mucositis Weekly Questionnaire (OMWQ), administered at routine infusion visits. Data on chemotherapy dose modifications or delays will also be recorded.
To assess effectiveness, the outcomes from the prospective cohort will be compared to a retrospective historical control group composed of patients previously treated at the same facility with similar chemotherapy regimens but who did not receive dexamethasone mouthwash. Data from the control group will be collected from the electronic medical record (EMR) and will include oral mucositis incidence and severity, chemotherapy regimens, and any treatment delays due to mucositis. Matching or statistical adjustment methods (e.g., multivariable regression) may be used to account for confounding variables.
The primary endpoint is the incidence of grade ≥2 oral mucositis during chemotherapy, graded per CTCAE v5.0. Secondary endpoints include overall mucositis severity, chemotherapy delays or reductions, patient-reported symptoms (pain, discomfort, interference with eating or speaking), and adherence to mouthwash use.
Risks related to the intervention are expected to be minimal and may include oral thrush, burning sensation, or changes in taste. Dexamethasone is generally well tolerated in topical formulations, and safety monitoring will focus on local and systemic reactions potentially linked to steroid use.
There is no cost to participate in the study. All study activities are conducted as part of routine care at Woman's Cancer Pavilion. The study is funded by a grant from the Foundation for Woman's.
This study will not collect biospecimens. No genetic testing will be performed. Only de-identified data will be used in any publication or external reporting. Identifiable information from the prospective and historical cohorts will be stored securely in compliance with institutional and federal regulations.
This research aims to generate evidence to support proactive, standardized interventions to prevent chemotherapy-induced oral mucositis and improve supportive care for patients undergoing cancer treatment.
- Conditions
- Oral Mucositis Due to Chemotherapy
- Being tested
- Dexamethasone Mouthwash
- Keywords
- oral mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone MouthwashDrug
Participants will use 10 mL of alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL) as a swish-and-spit rinse for 2 minutes, four times per day. Use will begin during the first week of chemotherapy and continue for at least 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Mouthwash Intervention Group | Experimental | Participants in this arm will receive an alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL solution). They will be instructed to swish and spit 10 mL of the mouthwash for 2 minutes, four times daily, beginning in the first week of chemotherapy. Mouthwash use will continue for at least 8 weeks. Receives: Drug: Dexamethasone Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥2 Oral Mucositis
Proportion of participants who develop grade 2 or higher oral mucositis, as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0), during chemotherapy treatment while using dexamethasone mouthwash.
Measured: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Secondary outcomes (5)
Severity of Oral Mucositis Symptoms (Clinician Assessed)
Severity of oral mucositis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) grading scale.
Measured: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Severity of Oral Mucositis Symptoms (Patient-Reported)
Participants will report symptoms using the Oral Mucositis Weekly Questionnaire (OMWQ), which includes ratings for mouth and throat soreness, pain, and interference with eating, drinking, and speaking.
Measured: From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)
Chemotherapy Treatment Modifications Due to Oral Mucositis
Number of chemotherapy dose delays, reductions, or discontinuations that are documented as being caused by oral mucositis symptoms.
Measured: Up to 16 weeks
Number of Participants With Adverse Events Related to Dexamethasone Mouthwash
Number of participants who experience at least one adverse event (AE) deemed related to mouthwash use, including but not limited to oral candidiasis or allergic response.
Measured: Up to 16 weeks
Mouthwash Adherence
Self-reported and staff-monitored adherence to the prescribed mouthwash use protocol.
Measured: Daily for the first 8 weeks of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start2 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis Due to ChemotherapyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley R Edwards, PhD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287826
- Sponsor's protocol ID
- RP-25-033-WH
- Acronym
- SMILE
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, it is not yet known whether individual participant data (IPD) from this study will be shared. If shared, the IPD may include de-identified data sets containing clinical outcomes such as oral mucositis severity, adverse events, and participant-reported symptom scores. A final decision will be based on privacy protections, data use agreements, and institutional policies related to secondary data sharing.
Publications
Saigal B, Guerra L. Prevention of Stomatitis: Using Dexamethasone-Based Mouthwash to Inhibit Everolimus-Related Stomatitis. Clin J Oncol Nurs. 2018 Apr 1;22(2):211-217. doi: 10.1188/18.CJON.211-217.
PubMed 29547614Seiler S, Kosse J, Loibl S, Jackisch C. Adverse event management of oral mucositis in patients with breast cancer. Breast Care (Basel). 2014 Apr;9(4):232-7. doi: 10.1159/000366246.
PubMed 25404881Kuderer NM, Desai A, Lustberg MB, Lyman GH. Mitigating acute chemotherapy-associated adverse events in patients with cancer. Nat Rev Clin Oncol. 2022 Nov;19(11):681-697. doi: 10.1038/s41571-022-00685-3. Epub 2022 Oct 11.
PubMed 36221000Ruddy KJ, Zahrieh D, He J, Waechter B, Holleran JL, Lewis LD, Chow S, Beumer J, Weiss M, Trikalinos N, Faller B, Lustberg M, Rugo HS, Loprinzi C. Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701). Semin Oncol. 2023 Feb-Apr;50(1-2):7-10. doi: 10.1053/j.seminoncol.2023.01.001. Epub 2023 Jan 17.
PubMed 36693773Kuba S, Maeda S, Shibata K, Soutome S, Yamanouchi K, Matsumoto M, Tanaka A, Morita M, Hatachi T, Otsubo R, Yano H, Kawashita Y, Sato S, Taniguchi H, Kanetaka K, Umeda M, Nagayasu T, Eguchi S. EFFICACY AND SAFETY OF A DEXAMETHASONE-BASED MOUTHWASH TO PREVENT CHEMOTHERAPY-INDUCED STOMATITIS IN WOMEN WITH BREAST CANCER: A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 2 STUDY. J Evid Based Dent Pract. 2023 Sep;23(3):101896. doi: 10.1016/j.jebdp.2023.101896. Epub 2023 Jun 11.
PubMed 37689451Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, Pluard TJ, Dhillon N, Hwang LC, Nangia C, Mayer IA, Meiller TF, Chambers MS, Sweetman RW, Sabo JR, Litton JK. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol. 2017 May;18(5):654-662. doi: 10.1016/S1470-2045(17)30109-2. Epub 2017 Mar 15.
PubMed 28314691
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Dexamethasone Mouthwash in Lowering Episodes of Oral Mucositis Among Patients With Cancer: The SMILE Study
- ClinicalTrials.gov ID
- NCT07287826
- Acronym / sponsor ID
- SMILE / RP-25-033-WH
- Conditions
- Oral Mucositis Due to Chemotherapy
- Keywords
- oral mucositis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Dec 2025 (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.
The goal of this clinical trial is to learn if a steroid mouthwash (dexamethasone) can prevent mouth sores caused by chemotherapy in adults with cancer. The main questions it aims to answer are:
Does using dexamethasone mouthwash before and during chemotherapy lower the chance of getting moderate to severe mouth sores?
Can this approach reduce pain and improve comfort during chemotherapy?
Researchers will compare patients using the mouthwash to a historical group of patients who received similar chemotherapy but did not use the mouthwash, to see if the mouthwash helps prevent mouth sores.
Participants will:
Use a steroid mouthwash (4 times daily) for up to 8 weeks during chemotherapy
Complete a short weekly survey about mouth discomfort during infusion visits
Detailed description
Oral mucositis is a common and painful side effect of chemotherapy, particularly in patients receiving regimens such as anthracyclines and taxanes. It can lead to difficulty eating, drinking, and speaking, and may result in treatment delays or dose reductions. Recent studies suggest that prophylactic use of dexamethasone mouthwash may reduce the incidence and severity of chemotherapy-induced oral mucositis. However, optimal dosing schedules and broader applicability across cancer types remain unclear.
The SMILE Study is a single-arm, prospective clinical trial designed to evaluate the effectiveness of dexamethasone mouthwash in preventing oral mucositis in adults receiving specific types of chemotherapy for cancer. Participants will be enrolled before beginning chemotherapy regimens known to be associated with a high risk of mucositis. All participants will receive dexamethasone mouthwash to use as a swish-and-spit rinse for 8 weeks.
The study will enroll at least 45 participants. Participants will be monitored throughout their chemotherapy treatment for signs and symptoms of oral mucositis, treatment adherence, and potential adverse events related to the mouthwash. Patient-reported outcomes will be collected using the Oral Mucositis Weekly Questionnaire (OMWQ), administered at routine infusion visits. Data on chemotherapy dose modifications or delays will also be recorded.
To assess effectiveness, the outcomes from the prospective cohort will be compared to a retrospective historical control group composed of patients previously treated at the same facility with similar chemotherapy regimens but who did not receive dexamethasone mouthwash. Data from the control group will be collected from the electronic medical record (EMR) and will include oral mucositis incidence and severity, chemotherapy regimens, and any treatment delays due to mucositis. Matching or statistical adjustment methods (e.g., multivariable regression) may be used to account for confounding variables.
The primary endpoint is the incidence of grade ≥2 oral mucositis during chemotherapy, graded per CTCAE v5.0. Secondary endpoints include overall mucositis severity, chemotherapy delays or reductions, patient-reported symptoms (pain, discomfort, interference with eating or speaking), and adherence to mouthwash use.
Risks related to the intervention are expected to be minimal and may include oral thrush, burning sensation, or changes in taste. Dexamethasone is generally well tolerated in topical formulations, and safety monitoring will focus on local and systemic reactions potentially linked to steroid use.
There is no cost to participate in the study. All study activities are conducted as part of routine care at Woman's Cancer Pavilion. The study is funded by a grant from the Foundation for Woman's.
This study will not collect biospecimens. No genetic testing will be performed. Only de-identified data will be used in any publication or external reporting. Identifiable information from the prospective and historical cohorts will be stored securely in compliance with institutional and federal regulations.
This research aims to generate evidence to support proactive, standardized interventions to prevent chemotherapy-induced oral mucositis and improve supportive care for patients undergoing cancer treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Mouthwash Intervention Group | Experimental | Drug: Dexamethasone MouthwashParticipants in this arm will receive an alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL solution). They will be instructed to swish and spit 10 mL of the mouthwash for 2 minutes, four times daily, beginning in the first week of chemotherapy. Mouthwash use will continue for at least 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Confirmed cancer diagnosis
- Scheduled to receive or receiving chemotherapy known to be associated with oral mucositis (e.g., anthracyclines and taxanes)
- Ability to provide informed consent
- Ability to comply with study procedures
Key exclusion criteria (12 listed)
- Current tobacco usage or usage within the past 6 weeks.
- HIV/AIDS
- Gastrointestinal disorder (such as Crohn's disease, ulcerative colitis, or celiac disease)
- History of cold sores (herpes simplex virus)
- Herpes zoster (oral shingles) within the past 6 weeks
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 |
|---|---|---|
| Dexamethasone MouthwashParticipants will use 10 mL of alcohol-free dexamethasone mouthwash (0.5 mg per 5 mL) as a swish-and-spit rinse for 2 minutes, four times per day. Use will begin during the first week of chemotherapy and continue for at least 8 weeks. | Drug | Dexamethasone Mouthwash Intervention Group |
Primary outcome
Incidence of Grade ≥2 Oral Mucositis
Time frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Proportion of participants who develop grade 2 or higher oral mucositis, as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0), during chemotherapy treatment while using dexamethasone mouthwash.
5 secondary outcomes
Severity of Oral Mucositis Symptoms (Clinician Assessed)
Time frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)
Severity of Oral Mucositis Symptoms (Patient-Reported)
Time frame: From start of chemotherapy through completion of chemotherapy cycle 1 (up to 8 weeks)
Chemotherapy Treatment Modifications Due to Oral Mucositis
Time frame: Up to 16 weeks
Number of Participants With Adverse Events Related to Dexamethasone Mouthwash
Time frame: Up to 16 weeks
Mouthwash Adherence
Time frame: Daily for the first 8 weeks of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 29547614Saigal B, Guerra L. Prevention of Stomatitis: Using Dexamethasone-Based Mouthwash to Inhibit Everolimus-Related Stomatitis. Clin J Oncol Nurs. 2018 Apr 1;22(2):211-217. doi: 10.1188/18.CJON.211-217.
- Background: PubMed 25404881Seiler S, Kosse J, Loibl S, Jackisch C. Adverse event management of oral mucositis in patients with breast cancer. Breast Care (Basel). 2014 Apr;9(4):232-7. doi: 10.1159/000366246.
- Background: PubMed 36221000Kuderer NM, Desai A, Lustberg MB, Lyman GH. Mitigating acute chemotherapy-associated adverse events in patients with cancer. Nat Rev Clin Oncol. 2022 Nov;19(11):681-697. doi: 10.1038/s41571-022-00685-3. Epub 2022 Oct 11.
- Background: PubMed 36693773Ruddy KJ, Zahrieh D, He J, Waechter B, Holleran JL, Lewis LD, Chow S, Beumer J, Weiss M, Trikalinos N, Faller B, Lustberg M, Rugo HS, Loprinzi C. Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701). Semin Oncol. 2023 Feb-Apr;50(1-2):7-10. doi: 10.1053/j.seminoncol.2023.01.001. Epub 2023 Jan 17.
- Background: PubMed 37689451Kuba S, Maeda S, Shibata K, Soutome S, Yamanouchi K, Matsumoto M, Tanaka A, Morita M, Hatachi T, Otsubo R, Yano H, Kawashita Y, Sato S, Taniguchi H, Kanetaka K, Umeda M, Nagayasu T, Eguchi S. EFFICACY AND SAFETY OF A DEXAMETHASONE-BASED MOUTHWASH TO PREVENT CHEMOTHERAPY-INDUCED STOMATITIS IN WOMEN WITH BREAST CANCER: A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 2 STUDY. J Evid Based Dent Pract. 2023 Sep;23(3):101896. doi: 10.1016/j.jebdp.2023.101896. Epub 2023 Jun 11.
- Background: PubMed 28314691Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, Pluard TJ, Dhillon N, Hwang LC, Nangia C, Mayer IA, Meiller TF, Chambers MS, Sweetman RW, Sabo JR, Litton JK. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol. 2017 May;18(5):654-662. doi: 10.1016/S1470-2045(17)30109-2. Epub 2017 Mar 15.
- Individual participant dataSharing planned: Undecided. At this time, it is not yet known whether individual participant data (IPD) from this study will be shared. If shared, the IPD may include de-identified data sets containing clinical outcomes such as oral mucositis severity, adverse events, and participant-reported symptom scores. A final decision will be based on privacy protections, data use agreements, and institutional policies related to secondary data sharing.
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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.
Ashley R Edwards, PhD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Mouthwash in people with Oral Mucositis Due to Chemotherapy, run by Woman's at 1 site 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley R Edwards, PhD (225-421-9185, ashley.edwards@womans.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥2 Oral Mucositis (time frame: From start of chemotherapy through completion of first chemotherapy cycle (up to 8 weeks)). 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 NCT07287826, which also lists 6 linked publications.
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 25 Jun 2026.