Radiation-induced Oral MucositisNCT07538934
A Phase II Prospective, Open-Label, Randomized, Multicenter Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Receiving Intensity-Modulated Radiotherapy
A study testing Kangfu Spray and Standard Oral Care in people with Radiation-induced Oral Mucositis and Oral Malignancy, run by YE ZHANG.
Trial summary
This is a prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Oral Mucositis, Oral Malignancy
- What is being tested?
- Kangfu Spray and Standard Oral Care
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2029
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed oral malignancy.
- Age 18 to 80 years.
- Karnofsky Performance Status (KPS) score >=70.
- Planned to receive definitive or postoperative adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemoradiotherapy, after multidisciplinary team evaluation.
- Adequate organ function, including white blood cell count >=2.0 x 10^9/L, absolute neutrophil count >=1.0 x 10^9/L, platelet count >=80 x 10^9/L, hemoglobin >=90 g/L, serum creatinine <=1.5 x upper limit of normal (ULN) or creatinine clearance >=50 mL/min, total bilirubin <=1.5 x ULN, and AST/ALT <=2.5 x ULN.
- Able to understand and comply with study procedures.
- Written informed consent provided.
Who cannot join
- Known allergy to Kangfu Spray or severe allergic predisposition.
- Uncontrolled immune-related oral mucosal disease or prior related immune mucosal disease.
- Pregnancy or breastfeeding.
- Prior radiotherapy to the head and neck region.
- Any severe concomitant disease or condition that, in the investigator's judgment, makes the participant unsuitable for participation.
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: A Prospective, Open-Label, Randomized, Controlled, Multicenter Phase II Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Undergoing Intensity-Modulated Radiotherapy
This is a prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy.
Eligible participants will undergo definitive or postoperative adjuvant IMRT according to multidisciplinary team recommendations. Participants in the experimental group will receive Kangfu Spray prophylactically from the first day of radiotherapy until completion of radiotherapy, in addition to standard oral care. The primary endpoint is the incidence of severe radiation-induced oral mucositis, defined as World Health Organization (WHO) grade 3 or higher. Secondary endpoints include time to onset and duration of severe oral mucositis, incidence and duration of any oral mucositis, oral ulcer and pain scores, radiotherapy interruption, opioid analgesic use, nutritional indicators, quality of life, and safety. Exploratory analyses will evaluate lymphocytes, inflammatory factors, and microbiota in blood and saliva.
Read the detailed description
Radiation-induced oral mucositis is a common and clinically significant toxicity in patients with oral and head and neck malignancies receiving radiotherapy, particularly when concurrent chemotherapy is administered. Severe mucositis may result in pain, impaired oral intake, weight loss, treatment interruption, and reduced quality of life. Despite standard supportive care, the incidence of severe oral mucositis remains substantial.
Kangfu Spray is a medical radiation-protective product intended to reduce radiation-induced mucosal injury. According to the protocol and ethics materials, its proposed mechanism is related to free-radical scavenging, mainly through superoxide dismutase (SOD), thereby mitigating radiation-related mucosal damage. Preliminary data cited in the protocol suggest that Kangfu Spray may reduce the incidence and severity of radiation-induced oral mucositis and delay its onset in patients receiving radiotherapy for head and neck malignancies.
This study is an investigator-initiated, prospective, open-label, randomized, controlled, multicenter phase II trial. A total of 140 patients with histologically confirmed oral malignancies will be enrolled across 4 hospitals. Eligible patients must be scheduled to receive definitive or postoperative adjuvant IMRT, with or without concurrent platinum-based chemotherapy. Participants will be randomized to receive either Kangfu Spray plus standard oral care or standard oral care alone. In the experimental group, Kangfu Spray will be administered from the first day of radiotherapy until completion of radiotherapy, with 10 mL used at least 5 times daily and each administration lasting at least 1 minute. Suggested administration times are in the morning, before bedtime, approximately 30 minutes before radiotherapy, immediately after radiotherapy, and approximately 30 minutes after radiotherapy.
Oral mucositis will be assessed during radiotherapy and for 1 month after radiotherapy using WHO grading, the Oral Mucositis Assessment Scale (OMAS), and the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness items. Additional evaluations include quality of life assessed by EORTC QLQ-C30, opioid analgesic use, nutritional indicators including body weight and PG-SGA, radiotherapy interruption, and safety assessed according to CTCAE version 5.0. Exploratory analyses will assess lymphocytes, inflammatory factors, and microbiota in blood and saliva. The primary endpoint is the incidence of severe oral mucositis, defined as WHO grade 3 or higher.
- Conditions
- Radiation-induced Oral Mucositis, Oral Malignancy
- Being tested
- Kangfu Spray, Standard Oral Care
- Keywords
- Kangfu Spray, radiation-induced oral mucositis, oral cancer, chemoradiotherapy, oral mucositis prevention
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangfu SprayDevice
Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed.
Standard Oral CareOther
Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT.
| Study group | Role | What they receive |
|---|---|---|
| Kangfu Spray plus Standard Oral Care | Experimental | Participants receive Kangfu Spray prophylaxis in addition to standard oral care, oral hygiene education, and supportive care during intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy. Receives: Device: Kangfu Spray |
| Standard Oral Care | Active comparator | Participants receive standard oral care, including oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT, with or without concurrent platinum-based chemotherapy. Receives: Other: Standard Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Radiation-Induced Oral Mucositis
Incidence of severe oral mucositis defined as World Health Organization (WHO) grade 3 or higher.
Measured: From the start of radiotherapy to 1 month after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to 1 of 2 parallel groups: Kangfu Spray plus standard oral care or standard oral care alone during IMRT, with or without concurrent platinum-based chemotherapy.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YE ZHANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YE ZHANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538934
- Sponsor's protocol ID
- NCC 016113
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in order to protect participant confidentiality and because no formal external data-sharing plan has been established for this investigator-initiated study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Randomized, Controlled, Multicenter Phase II Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Undergoing Intensity-Modulated Radiotherapy
- ClinicalTrials.gov ID
- NCT07538934
- Acronym / sponsor ID
- NCC 016113
- Conditions
- Radiation-induced Oral Mucositis, Oral Malignancy
- Keywords
- Kangfu Spray, radiation-induced oral mucositis, oral cancer, chemoradiotherapy, oral mucositis prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- YE ZHANGUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 20 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 prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy.
Eligible participants will undergo definitive or postoperative adjuvant IMRT according to multidisciplinary team recommendations. Participants in the experimental group will receive Kangfu Spray prophylactically from the first day of radiotherapy until completion of radiotherapy, in addition to standard oral care. The primary endpoint is the incidence of severe radiation-induced oral mucositis, defined as World Health Organization (WHO) grade 3 or higher. Secondary endpoints include time to onset and duration of severe oral mucositis, incidence and duration of any oral mucositis, oral ulcer and pain scores, radiotherapy interruption, opioid analgesic use, nutritional indicators, quality of life, and safety. Exploratory analyses will evaluate lymphocytes, inflammatory factors, and microbiota in blood and saliva.
Detailed description
Radiation-induced oral mucositis is a common and clinically significant toxicity in patients with oral and head and neck malignancies receiving radiotherapy, particularly when concurrent chemotherapy is administered. Severe mucositis may result in pain, impaired oral intake, weight loss, treatment interruption, and reduced quality of life. Despite standard supportive care, the incidence of severe oral mucositis remains substantial.
Kangfu Spray is a medical radiation-protective product intended to reduce radiation-induced mucosal injury. According to the protocol and ethics materials, its proposed mechanism is related to free-radical scavenging, mainly through superoxide dismutase (SOD), thereby mitigating radiation-related mucosal damage. Preliminary data cited in the protocol suggest that Kangfu Spray may reduce the incidence and severity of radiation-induced oral mucositis and delay its onset in patients receiving radiotherapy for head and neck malignancies.
This study is an investigator-initiated, prospective, open-label, randomized, controlled, multicenter phase II trial. A total of 140 patients with histologically confirmed oral malignancies will be enrolled across 4 hospitals. Eligible patients must be scheduled to receive definitive or postoperative adjuvant IMRT, with or without concurrent platinum-based chemotherapy. Participants will be randomized to receive either Kangfu Spray plus standard oral care or standard oral care alone. In the experimental group, Kangfu Spray will be administered from the first day of radiotherapy until completion of radiotherapy, with 10 mL used at least 5 times daily and each administration lasting at least 1 minute. Suggested administration times are in the morning, before bedtime, approximately 30 minutes before radiotherapy, immediately after radiotherapy, and approximately 30 minutes after radiotherapy.
Oral mucositis will be assessed during radiotherapy and for 1 month after radiotherapy using WHO grading, the Oral Mucositis Assessment Scale (OMAS), and the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness items. Additional evaluations include quality of life assessed by EORTC QLQ-C30, opioid analgesic use, nutritional indicators including body weight and PG-SGA, radiotherapy interruption, and safety assessed according to CTCAE version 5.0. Exploratory analyses will assess lymphocytes, inflammatory factors, and microbiota in blood and saliva. The primary endpoint is the incidence of severe oral mucositis, defined as WHO grade 3 or higher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to 1 of 2 parallel groups: Kangfu Spray plus standard oral care or standard oral care alone during IMRT, with or without concurrent platinum-based chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Kangfu Spray plus Standard Oral Care | Experimental | Device: Kangfu SprayParticipants receive Kangfu Spray prophylaxis in addition to standard oral care, oral hygiene education, and supportive care during intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy. |
| Standard Oral Care | Active comparator | Other: Standard Oral CareParticipants receive standard oral care, including oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT, with or without concurrent platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed oral malignancy.
- Age 18 to 80 years.
- Karnofsky Performance Status (KPS) score >=70.
- Planned to receive definitive or postoperative adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemoradiotherapy, after multidisciplinary team evaluation.
- Adequate organ function, including white blood cell count >=2.0 x 10^9/L, absolute neutrophil count >=1.0 x 10^9/L, platelet count >=80 x 10^9/L, hemoglobin >=90 g/L, serum creatinine <=1.5 x upper limit of normal (ULN) or creatinine clearance >=50 mL/min, total bilirubin <=1.5 x ULN, and AST/ALT <=2.5 x ULN.
Key exclusion criteria (5 listed)
- Known allergy to Kangfu Spray or severe allergic predisposition.
- Uncontrolled immune-related oral mucosal disease or prior related immune mucosal disease.
- Pregnancy or breastfeeding.
- Prior radiotherapy to the head and neck region.
- Any severe concomitant disease or condition that, in the investigator's judgment, makes the participant unsuitable for participation.
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 |
|---|---|---|
| Kangfu SprayStandard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed. | Device | Kangfu Spray plus Standard Oral Care |
| Standard Oral CareStandard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT. | Other | Standard Oral Care |
Primary outcome
Incidence of Severe Radiation-Induced Oral Mucositis
Time frame: From the start of radiotherapy to 1 month after completion of radiotherapy
Incidence of severe oral mucositis defined as World Health Organization (WHO) grade 3 or higher.
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 20 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared in order to protect participant confidentiality and because no formal external data-sharing plan has been established for this investigator-initiated study.
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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 study testing Kangfu Spray and Standard Oral Care in people with Radiation-induced Oral Mucositis and Oral Malignancy, run by YE ZHANG.
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 7 inclusion and 5 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 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ye Zhang, MD (010 8778 8709, Drzye1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Radiation-Induced Oral Mucositis (time frame: From the start of radiotherapy to 1 month after completion of radiotherapy). 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 20 Apr 2026.