A Phase II Prospective, Open-Label, Randomized, Multicenter Study of Kangfu Spray for the Prevent… (NCT07538934) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
140 participantsStarted 2026-07-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Severe Radiation-Induced Oral Mucositis
Timeframe: From the start of radiotherapy to 1 month after completion of radiotherapy