Radiotherapy-induced Oral MucositisPhase 2NCT07339774
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
A Phase 2 study testing Zishui Daohuo oral liquid combined with Kujiu mouthwash and Radiotherapy in people with Radiotherapy-induced Oral Mucositis, run by West China Hospital at 1 site in China.
Trial summary
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiotherapy-induced Oral Mucositis
- What is being tested?
- Zishui Daohuo oral liquid combined with Kujiu mouthwash and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2026to 30 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Age range: 18 to 65 years old (including 18 and 65 years old);
- Eastern Cooperative Oncology Group performance status of ≤2;
- Radiotherapy or concurrent chemoradiotherapy is required;
- The main organ functions well;
- Sign informed consent.
Who cannot join
- Allergic constitution (such as those known to be allergic to two or more drugs);
- Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
JiaYi Yu Doctor contact
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xingchen Peng Ph.D, 18980606753, pxx2014@163.com
About this study
Official title: Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
Read the detailed description
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral solution with a mouthwash in reducing the duration of severe radiation-induced oral mucositis (RIOM). The study addresses two primary questions: (1) whether the combined use of the TCM oral solution and mouthwash can effectively shorten the duration of severe RIOM, and (2) whether their use is associated with adverse events in patients undergoing radiotherapy.
Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time.
The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.
- Conditions
- Radiotherapy-induced Oral Mucositis
- Being tested
- Placebo oral liquid and mouthwash, Zishui Daohuo oral liquid combined with Kujiu mouthwash, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral liquid and mouthwashDrug
Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients
Zishui Daohuo oral liquid combined with Kujiu mouthwashDrug
Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
RadiotherapyRadiation
One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Zishui Daohuo oral liquid combined with Kujiu mouthwash group. | Experimental | Not described Receives: Drug: Zishui Daohuo oral liquid combined with Kujiu mouthwash; Radiation: Radiotherapy |
| Placebo oral liquid and mouthwash | Placebo comparator | Not described Receives: Drug: Placebo oral liquid and mouthwash; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of severe oral mucositis (RTOG grade≥3)
The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Secondary outcomes (5)
The time to onset of severe oral mucositis (RTOG grade≥3)
Time from the first day of radiotherapy to the first determination of SOM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of any-grade oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Relief rate of oral mucositis
The proportion of patients whose oral mucositis resolved to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start5 Nov 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Aug 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 West China HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339774
- Sponsor's protocol ID
- 2024(1774)
- Status last verified
- Nov 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.
- ClinicalTrials.gov ID
- NCT07339774
- Acronym / sponsor ID
- 2024(1774)
- Conditions
- Radiotherapy-induced Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Nov 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 14 Jan 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.
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
Detailed description
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral solution with a mouthwash in reducing the duration of severe radiation-induced oral mucositis (RIOM). The study addresses two primary questions: (1) whether the combined use of the TCM oral solution and mouthwash can effectively shorten the duration of severe RIOM, and (2) whether their use is associated with adverse events in patients undergoing radiotherapy.
Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time.
The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zishui Daohuo oral liquid combined with Kujiu mouthwash group. | Experimental | Drug: Zishui Daohuo oral liquid combined with Kujiu mouthwash, Radiation: Radiotherapy |
| Placebo oral liquid and mouthwash | Placebo comparator | Drug: Placebo oral liquid and mouthwash, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Age range: 18 to 65 years old (including 18 and 65 years old);
- Eastern Cooperative Oncology Group performance status of ≤2;
- Radiotherapy or concurrent chemoradiotherapy is required;
- The main organ functions well;
Key exclusion criteria (6 listed)
- Allergic constitution (such as those known to be allergic to two or more drugs);
- Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
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 |
|---|---|---|
| Placebo oral liquid and mouthwashPlacebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients | Drug | Placebo oral liquid and mouthwash |
| Zishui Daohuo oral liquid combined with Kujiu mouthwashOral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash. | Drug | Zishui Daohuo oral liquid combined with Kujiu mouthwash group. |
| RadiotherapyOne of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy. | Radiation | Placebo oral liquid and mouthwash, Zishui Daohuo oral liquid combined with Kujiu mouthwash group. |
Primary outcome
The duration of severe oral mucositis (RTOG grade≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.
5 secondary outcomes
The time to onset of severe oral mucositis (RTOG grade≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of any-grade oral mucositis (OM)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The time to onset of any-grade oral mucositis (OM)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Relief rate of oral mucositis
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
Adverse events
Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.
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 6 Nov 2026.
Related trials for Radiotherapy-induced Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
Mucositis Oral, Head and Neck Cancer
Enrolling by invitationPhase 1/2
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Mucositis Oral, Head & Neck Cancer
Not yet recruiting
Citrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis
Radiation-induced Oral Mucositis, Head and Neck Cancer
Active, not recruitingPhase 2/3
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
Nasopharyngeal Cancinoma (NPC)
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.
JiaYi Yu Doctor contact
Xingchen Peng, Professor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zishui Daohuo oral liquid combined with Kujiu mouthwash and Radiotherapy in people with Radiotherapy-induced Oral Mucositis, run by West China Hospital at 1 site in China.
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 6 inclusion and 6 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 6 Nov 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 China. 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?
Contact Xingchen Peng Professor (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of severe oral mucositis (RTOG grade≥3) (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.). 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 6 Nov 2026.