Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

National Taiwan University Hospital60 enrolled

Overview

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 (FSFI) scores. Follow-up assessments will be conducted to determine whether CH2 vaginal gel or vaginal rehabilitation can improve post-radiotherapy vaginal health and enhance the long-term quality of life for women with cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gynecologic Malignancy

Interventions

CH2 vaginal gelOTHER

12-week intervention with CH2 vaginal gel

vaginal rehabilitation exercisesOTHER

12-week intervention with vaginal rehabilitation exercises

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Female Sexual Function Index (FSFI) score

Female Sexual Function Index (FSFI) score. The score ranges from a minimum of 2 to a maximum of 36. Higher scores indicate better sexual function.

Time frame: From enrollment to the end of intervention at at 3, 6, and 12 months

Central Contacts

Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD

CONTACT

886-2-23123456 ntuhrec@ntuh.gov.tw

Data from ClinicalTrials.gov

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