Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
Trial Parameters
Brief Summary
This is a prospective clinical trial planning to enroll female patients who have completed pelvic radiotherapy. Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises. The primary endpoint is the change in the Female Sexual Function Index scores.
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged between 20 and 70 years. 2. Completion of pelvic radiotherapy for gynecologic cancer, which may include external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of both. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Exclusion Criteria: 1. Individuals under the age of 18. 2. Presence of distant metastases or a history of malignancy currently under treatment within the past five years (excluding non-melanoma skin cancer). 3. Presence of severe comorbidities, such as uncontrolled diabetes, cardiovascular disease, or autoimmune disorders that may interfere with treatment or study participation. 4. Diagnosed psychiatric disorders or significant social factors that may prevent adherence to study requirements or completion of follow-up evaluations. 5. Inability to self-administer vaginal gel or vaginal rehabilitation exercises.