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

NCT07538934 | Not Yet Recruiting

• 1 other identifier: NCC 016113
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Radiation-induced Oral Mucositis; Oral Malignancy

Keywords

Kangfu Spray; radiation-induced oral mucositis; oral cancer; chemoradiotherapy; oral mucositis prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Radiation-Induced Oral Mucositis

  Incidence of severe oral mucositis defined as World Health Organization (WHO) grade 3 or higher.

  From the start of radiotherapy to 1 month after completion of radiotherapy

Study Arms (2)

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.

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.

Other: Standard Oral Care

Interventions

Kangfu Spray DEVICE

Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed.

Kangfu Spray plus Standard Oral Care

Standard Oral Care OTHER

Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT.

Standard Oral Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YE ZHANG: lead

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Ye Zhang, MD

CONTACT

010 8778 8709; Drzye1983@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share