Radiotherapy-Induced Oral MucositisPhase 3NCT07543978
Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)
A Phase 3 study testing Modified Dahuang Huanglian Xiexin Mouthwash in people with Radiotherapy-Induced Oral Mucositis and Stomatitis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiotherapy-Induced Oral Mucositis, Stomatitis, Oral Mucositis
- What is being tested?
- Modified Dahuang Huanglian Xiexin Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2027
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years (inclusive) at the time of screening.
- Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.
- Planned to receive radiotherapy.
- No prior history of radiotherapy to the head and neck region.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):
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- Hemoglobin (Hb) ≥90 g/L Absolute neutrophil count (ANC)≥1.5×10⁹/L Platelet count (PLT) ≥80×10⁹/L Total bilirubin (BIL) < 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) > 50 mL/min
- Signed written informed consent prior to any study-related procedures.
- Judged by the investigator to be able to comply with the study protocol.
- Negative pregnancy test (for women of childbearing potential) at screening.
- Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Pre-existing oral mucositis prior to the start of radiotherapy.
- Prior radiotherapy to the head and neck region.
- Major surgery within 3 weeks prior to enrollment.
- Uncontrolled cardiac conditions or symptoms, including but not limited to:
- New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention
- Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
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- Active infection requiring systemic therapy.
- Known history of substance abuse, alcohol abuse, or drug addiction.
- Pregnancy or breastfeeding.
- Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
- Conditions
- Radiotherapy-Induced Oral Mucositis, Stomatitis, Oral Mucositis, Radiotherapy Side Effects
- Being tested
- Modified Dahuang Huanglian Xiexin Mouthwash, Placebo Mouthwash
- Keywords
- Radiotherapy-Induced Oral Mucositis, RTOM, Stomatitis, Oral Mucositis, Radiation Injury
- Medical subject headings
- Stomatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Dahuang Huanglian Xiexin MouthwashDrug
A Chinese herbal mouthwash formulation derived from the classic formula Dahuang Huanglian Xiexin Decoction, with additional ingredients to enhance its properties for radiation-induced oral mucositis. The active ingredients include Rhei Radix et Rhizoma, Coptidis Rhizoma, Scutellariae Radix, and other botanical components. It is prepared as a ready-to-use aqueous solution with standardized extraction and quality control procedures. The mouthwash is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing until the development of grade 3 or higher oral mucositis, as defined by the WHO or RTOG criteria. This intervention is distinguished from the placebo comparator by the presence of active herbal ingredients, and its appearance, color, taste, and packaging are matched by the placebo to enable double-blind conditions.
Placebo MouthwashDrug
A placebo mouthwash formulated to match the active intervention (Modified Dahuang Huanglian Xiexin Mouthwash) in appearance, color, taste, and packaging. It contains no active pharmaceutical ingredients and is composed of purified water with pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the herbal formulation. The mouthwash is supplied as a ready-to-use aqueous solution. It is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. This intervention is distinguished from the active comparator by the absence of active herbal ingredients and serves as a control to enable double-blind evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Placebo mouthwash matching the active intervention in appearance, color, taste, and packaging, containing no active pharmaceutical ingredients. It consists of purified water, pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the Modified Dahuang Huanglian Xiexin Mouthwash. Patients in this arm are instructed to rinse with 10 mL of the placebo solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as a control to evaluate the efficacy of the active intervention under double-blind conditions. Receives: Drug: Placebo Mouthwash |
| Experimental arm | Experimental | Modified Dahuang Huanglian Xiexin Mouthwash (Jiawei Dahuang Huanglian Xiexin Koufuye), an active Chinese herbal formulation. Patients in this arm are instructed to rinse with 10 mL of the active solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as the experimental intervention to evaluate its efficacy in reducing radiation-induced oral mucositis compared with a matched placebo under double-blind conditions. Receives: Drug: Modified Dahuang Huanglian Xiexin Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Proportion of participants who develop radiation-induced oral mucositis (RTOM) of any grade within 2 weeks after the start of radiotherapy, assessed using the WHO Oral Toxicity Scale or RTOG Acute Radiation Morbidity Scoring Criteria. Participants who develop grade ≥3 RTOM prior to the 2-week assessment point are also counted as having reached the primary endpoint.
Measured: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)
Secondary outcomes (4)
Time to Onset of Radiation-Induced Oral Mucositis
Time from the first day of radiotherapy to the first occurrence of any grade of RTOM, as assessed by WHO or RTOG criteria.
Measured: From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy.
Weekly Oropharyngeal Pain Score Measured by OMWQ
Change in oropharyngeal pain and functional impairment assessed weekly using the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). The OMWQ-HN consists of 12 items assessing mouth and throat soreness, functional limitations, and pain. All item scores are linearly transformed to a 0 to 100 scale, with higher scores indicating worse symptoms and greater functional impairment.
Measured: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Weekly Body Weight Change During Radiotherapy
Weekly change in body weight (kg) from baseline. Weight is measured at baseline and then weekly throughout the radiotherapy course.
Measured: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Quality of Life (EORTC QLQ-H&N35)
Weekly change in quality of life scores using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H\&N35). All scale scores range from 0 to 100, with higher scores indicating worse symptoms or lower quality of life. Assessments are performed weekly during the radiotherapy course and again at 4 weeks post-radiotherapy.
Measured: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy-Induced Oral MucositisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543978
- Sponsor's protocol ID
- RTOM-1
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07543978
- Acronym / sponsor ID
- RTOM-1
- Conditions
- Radiotherapy-Induced Oral Mucositis, Stomatitis, Oral Mucositis, Radiotherapy Side Effects
- Keywords
- Radiotherapy-Induced Oral Mucositis, RTOM, Stomatitis, Oral Mucositis, Radiation Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (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 is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Drug: Placebo MouthwashPlacebo mouthwash matching the active intervention in appearance, color, taste, and packaging, containing no active pharmaceutical ingredients. It consists of purified water, pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the Modified Dahuang Huanglian Xiexin Mouthwash. Patients in this arm are instructed to rinse with 10 mL of the placebo solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as a control to evaluate the efficacy of the active intervention under double-blind conditions. |
| Experimental arm | Experimental | Drug: Modified Dahuang Huanglian Xiexin MouthwashModified Dahuang Huanglian Xiexin Mouthwash (Jiawei Dahuang Huanglian Xiexin Koufuye), an active Chinese herbal formulation. Patients in this arm are instructed to rinse with 10 mL of the active solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as the experimental intervention to evaluate its efficacy in reducing radiation-induced oral mucositis compared with a matched placebo under double-blind conditions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 to 70 years (inclusive) at the time of screening.
- Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.
- Planned to receive radiotherapy.
- No prior history of radiotherapy to the head and neck region.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Pre-existing oral mucositis prior to the start of radiotherapy.
- Prior radiotherapy to the head and neck region.
- Major surgery within 3 weeks prior to enrollment.
- Uncontrolled cardiac conditions or symptoms, including but not limited to:
- New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention
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 |
|---|---|---|
| Modified Dahuang Huanglian Xiexin MouthwashA Chinese herbal mouthwash formulation derived from the classic formula Dahuang Huanglian Xiexin Decoction, with additional ingredients to enhance its properties for radiation-induced oral mucositis. The active ingredients include Rhei Radix et Rhizoma, Coptidis Rhizoma, Scutellariae Radix, and other botanical components. It is prepared as a ready-to-use aqueous solution with standardized extraction and quality control procedures. The mouthwash is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing until the development of grade 3 or higher oral mucositis, as defined by the WHO or RTOG criteria. This intervention is distinguished from the placebo comparator by the presence of active herbal ingredients, and its appearance, color, taste, and packaging are matched by the placebo to enable double-blind conditions. | Drug | Experimental arm |
| Placebo MouthwashA placebo mouthwash formulated to match the active intervention (Modified Dahuang Huanglian Xiexin Mouthwash) in appearance, color, taste, and packaging. It contains no active pharmaceutical ingredients and is composed of purified water with pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the herbal formulation. The mouthwash is supplied as a ready-to-use aqueous solution. It is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. This intervention is distinguished from the active comparator by the absence of active herbal ingredients and serves as a control to enable double-blind evaluation. | Drug | Control arm |
Primary outcome
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Time frame: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)
Proportion of participants who develop radiation-induced oral mucositis (RTOM) of any grade within 2 weeks after the start of radiotherapy, assessed using the WHO Oral Toxicity Scale or RTOG Acute Radiation Morbidity Scoring Criteria. Participants who develop grade ≥3 RTOM prior to the 2-week assessment point are also counted as having reached the primary endpoint.
4 secondary outcomes
Time to Onset of Radiation-Induced Oral Mucositis
Time frame: From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy.
Weekly Oropharyngeal Pain Score Measured by OMWQ
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Weekly Body Weight Change During Radiotherapy
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
Quality of Life (EORTC QLQ-H&N35)
Time frame: weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.
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 22 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified Dahuang Huanglian Xiexin Mouthwash in people with Radiotherapy-Induced Oral Mucositis and Stomatitis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chao Wan (+86-18062775069, wanc@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation (time frame: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.