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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DEVICE

Kangfu Spray

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

OTHER

Standard Oral Care

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

Sponsors & Collaborators

  • YE ZHANG

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-09-01
Completion
2029-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538934 on ClinicalTrials.gov