Oral MucositisPhase 2KEVLARxNCT05966194
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
A Phase 2 study testing RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2 in people with Oral Mucositis, run by EpicentRx, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Apr 2024to 1 Oct 2027
- Phase
- Phase 2
- 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
- Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.
- Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of > 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
- ECOG performance status ≤ 2.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3. Hemoglobin ≥ 9.0 g/dL
- Adequate renal and liver function as indicated by:
Show all 16Show fewer
- Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline phosphatase ≤ 2.5 x ULN
- Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.
- Age 18 years or older
- Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.
- Ability and willingness to understand and sign a written informed consent document.
- Women of childbearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
- Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been postmenopausal for at least 12 consecutive months
- Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.
Who cannot join
- Prior radiotherapy to the head and neck region.
- Prior induction chemotherapy.
- Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
- Patients with simultaneous primaries
- Stage IV, M1 (distant metastasis)
- Prior or current use of approved or investigational anticancer agent other than those provided in this study.
Show all 19Show fewer
- Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal (solid) diet
- Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason or prophylactic insertion of gastrostomy tube with dependency on tube feeding at baseline.
- Malignant tumors other than squamous cell carcinoma of the head and neck within last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator.
- Active infectious disease excluding oral candidiasis.
- Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at baseline.
- Untreated active oral or dental infection
- Known history of human immunodeficiency virus or active hepatitis B or C.
- Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (e.g, immunosuppression, uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)
- Use of the following within 48 hours of enrollment and duration of Oral Mucositis follow up: vitamin B12 (cobalamin) or synthetic vitamin B12, cyanocobalamin, or the vitamin B12 precursor, cobinamide, or any supplement or multivitamin with vitamin B12 or vitamin E in it since both vitamin B12 and vitamin E interact negatively with RRx-001.
- Use of prebiotics and probiotics
- Pregnant or nursing.
- Known allergies or intolerance to cisplatin or other platinum-containing compounds.
- Sjogren syndrome
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sandra and Malcolm Berman Cancer Institute
Baltimore, Maryland, 21204
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
The Ohio State University James Cancer Hospital & Solove Research Institute
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
East Carolina University School of Medicine
Greenville, North Carolina, 27834
Ballad Health
Johnson City, Tennessee, 37604
Miami Cancer Institute
Miami, Florida, 33176
Renown Regional Medical Center
Reno, Nevada, 89502
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
The University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.
Read the detailed description
The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.
- Conditions
- Oral Mucositis
- Being tested
- RRx-001, Intensity Modulated Radiation Therapy (IMRT), Cisplatin for injection 100 mg/m2
- Keywords
- Head and Neck Cancer, Neck cancer, Oral cancer, Mucositis, Squamous cell carcinoma (SCC), HPV, Oropharynx, Oral cavity, IMRT
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Mouth Neoplasms, Mucositis, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001Drug
RRx-001 for injection (4 mg or 8 mg)
Intensity Modulated Radiation Therapy (IMRT)Radiation
Intensity Modulated Radiation Therapy of up to 72 Gy
Cisplatin for injection 100 mg/m2Drug
Cisplatin for injection 100 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) | Experimental | Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period Receives: Drug: RRx-001; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2 |
| RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT) | Experimental | Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period. Receives: Drug: RRx-001; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2 |
| Placebo Pre-Treatment + Chemoradiation Therapy (CRT) | Placebo comparator | No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period. Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin for injection 100 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
The incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT
Measured: Estimated up to 18 Months
Secondary outcomes (13)
Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
Duration of SOM (through the last day of radiation therapy, DoSOM). Its principal analysis employs the probability of being in response (PBIR), an intuitive concept based on the realization that the duration of response which is quantified as the area under the curve delimited by the duration of exposure (x axis) and the response probability (y axis).
Measured: Estimated up to 18 Months
Duration of Severe Oral Mucositis (SOM) through 60 Gy
Duration of SOM (through 60 Gy, DoSOM) is compared between RRx-001 arms and Placebo using a two-sided log-rank test.
Measured: Estimated up to 18 Months
Time to onset of Sever Oral Mucositis (ttSOM)
Time onset to SOM (ttSOM) is defined as the time interval measured from the start of the observation period to the first time SOM is observed.
Measured: Estimated up to 18 Months
Incidence and severity of dysphagia
Incidence and severity of dysphagia will be analyzed similarly to the primary efficacy endpoint.
Measured: Estimated up to 18 Months
Cumulative radiation dose to onset of SOM
Cumulative radiation dose to onset of SOM is compared between RRx-001 arms and placebo
Measured: Estimated up to 18 Months
Incidence of grade 4 oral mucositis
Incidence of grade 4 oral mucositis through 60 Gy
Measured: Estimated up to 18 Months
Narcotic use through resolution of SOM
Narcotic use through resolution of SOM will be analyzed similarly to the cumulative radiation dose
Measured: Estimated up to 18 Months
Incidence of Severe Oral Mucositis through 60 Gy of the Radiation Treatment Plan
incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through 60 Gy
Measured: Estimated up to 18 Months
Progression free survival (PFS)
Progression free survival (PFS)
Measured: Estimated up to 24 Months
Degree of Xerostomia
Degree of Xerostomia as analyzed by validated Xerostomia questionnaire 'XQ'
Measured: Estimated up to 24 Months
Xerostomia duration
Xerostomia duration as analyzed by validated Xerostomia questionnaire 'XQ'
Measured: Estimated up to 24 Months
Time to onset of dysphagia
Time to onset of dysphagia
Measured: Estimated up to 24 Months
Duration of dysphagia
Duration of dysphagia
Measured: Estimated up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start2 Apr 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meaghan Stirn, Study director, EpicentRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966194
- Sponsor's protocol ID
- K-01
- Acronym
- KEVLARx
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.
PubMed 36646388
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
- ClinicalTrials.gov ID
- NCT05966194
- Acronym / sponsor ID
- KEVLARx / K-01
- Conditions
- Oral Mucositis
- Keywords
- Head and Neck Cancer, Neck cancer, Oral cancer, Mucositis, Squamous cell carcinoma (SCC), HPV, Oropharynx, Oral cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Jul 2023 (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 purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.
Detailed description
The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) | Experimental | Drug: RRx-001, Radiation: Intensity Modulated Radiation Therapy (IMRT), Drug: Cisplatin for injection 100 mg/m2Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period |
| RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT) | Experimental | Drug: RRx-001, Radiation: Intensity Modulated Radiation Therapy (IMRT), Drug: Cisplatin for injection 100 mg/m2Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period. |
| Placebo Pre-Treatment + Chemoradiation Therapy (CRT) | Placebo comparator | Radiation: Intensity Modulated Radiation Therapy (IMRT), Drug: Cisplatin for injection 100 mg/m2No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.
- Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of > 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
- ECOG performance status ≤ 2.
- Participants must have adequate organ and marrow function as defined below:
- Adequate renal and liver function as indicated by:
Key exclusion criteria (19 listed)
- Prior radiotherapy to the head and neck region.
- Prior induction chemotherapy.
- Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
- Patients with simultaneous primaries
- Stage IV, M1 (distant metastasis)
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 |
|---|---|---|
| RRx-001RRx-001 for injection (4 mg or 8 mg) | Drug | RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT), RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) |
| Intensity Modulated Radiation Therapy (IMRT)Intensity Modulated Radiation Therapy of up to 72 Gy | Radiation | Placebo Pre-Treatment + Chemoradiation Therapy (CRT), RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT), RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) |
| Cisplatin for injection 100 mg/m2Cisplatin for injection 100 mg/m2 | Drug | Placebo Pre-Treatment + Chemoradiation Therapy (CRT), RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT), RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) |
Primary outcome
Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
Time frame: Estimated up to 18 Months
The incidence of SOM defined as the proportion of patients with any WHO Grade >= 3 (severe to life threatening) oral mucositis during the observation period from the start of CRT through IMRT
13 secondary outcomes
Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
Time frame: Estimated up to 18 Months
Duration of Severe Oral Mucositis (SOM) through 60 Gy
Time frame: Estimated up to 18 Months
Time to onset of Sever Oral Mucositis (ttSOM)
Time frame: Estimated up to 18 Months
Incidence and severity of dysphagia
Time frame: Estimated up to 18 Months
Cumulative radiation dose to onset of SOM
Time frame: Estimated up to 18 Months
Incidence of grade 4 oral mucositis
Time frame: Estimated up to 18 Months
Narcotic use through resolution of SOM
Time frame: Estimated up to 18 Months
Incidence of Severe Oral Mucositis through 60 Gy of the Radiation Treatment Plan
Time frame: Estimated up to 18 Months
Progression free survival (PFS)
Time frame: Estimated up to 24 Months
Degree of Xerostomia
Time frame: Estimated up to 24 Months
Xerostomia duration
Time frame: Estimated up to 24 Months
Time to onset of dysphagia
Time frame: Estimated up to 24 Months
Duration of dysphagia
Time frame: Estimated up to 24 Months
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 26 Jun 2026.
- Background: PubMed 36646388Bonomi M, Blakaj DM, Kabarriti R, Colvett K, Takiar V, Biagioli M, Bar-Ad V, Goyal S, Muzyka B, Niermann K, Abrouk N, Oronsky B, Reid T, Caroen S, Sonis S, Sher DJ. PREVLAR: Phase 2a Randomized Trial to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Head and Neck Chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):551-559. doi: 10.1016/j.ijrobp.2022.12.031. Epub 2023 Jan 14.
- 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.
Meaghan Stirn study director
EpicentRx, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RRx-001, Intensity Modulated Radiation Therapy (IMRT) and Cisplatin for injection 100 mg/m2 in people with Oral Mucositis, run by EpicentRx, Inc. at 14 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 16 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 26 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 14 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT) (time frame: Estimated up to 18 Months). 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 NCT05966194, 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 26 Jun 2026.