Gynecologic Malignant Tumors
Conditions
Interventions
Bioadhesive Film-Forming Gel Group:Bioadhesive Film-Forming Gel BID + Routine Vaginal Care
Sponsors
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the study, sign informed consent forms, and demonstrate good compliance; 2. Female, aged 18 years or older; 3. Histologically or cytologically confirmed gynecological malignancy; 4. Patients undergoing extrapelvic radiotherapy at screening who develop symptomatic radiation vaginitis (CTCAE Grade 2 or higher). 5. ECOG performance status 0-2.
Exclusion criteria
Exclusion criteria: 1. Known allergy to drug components (soy lecithin and glycerol dioleate); 2. Patients with central nervous system (CNS) disease or active CNS metastases; subjects with previously treated brain metastases may be enrolled if clinically stable for at least two weeks post-treatment; Untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no corticosteroid requirement) may be enrolled; 3. Patients who received other salvage therapies prior to the day of initiating bioadhesive film-forming gel treatment; 4. Patients currently participating in other clinical studies; 5. Lactating or pregnant women; 6. Other conditions deemed ineligible for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improvement in radiation vaginitis during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Score;Quality of Life; | — |
Countries
China
Contacts
Public ContactMingyi Li; Yanyi Zhu
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Outcome results
None listed