Using CH2 vaginal gel or vaginal rehabilitation exercises to improve vaginal health after pelvic radiotherapy

Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy

This project will test whether CH2 vaginal gel or vaginal rehabilitation exercises help women who completed pelvic radiotherapy improve vaginal health and sexual function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 70 Years
• Sex: Female
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06997887 on ClinicalTrials.gov

What this trial studies

This prospective enrollment will offer eligible women a 12-week intervention of either CH2 vaginal gel or a program of vaginal rehabilitation exercises. Participants will be followed with standardized questionnaires, including the Female Sexual Function Index (FSFI), to measure changes from baseline. The primary outcome is change in FSFI scores, with additional follow-up to track vaginal symptoms and quality of life. The goal is to determine which approach better supports long-term vaginal health after pelvic radiotherapy.

Who should consider this trial

Good fit: Women aged 20–70 who have completed pelvic radiotherapy for gynecologic cancer, have ECOG performance status 0–1, and can self-administer the assigned intervention and attend follow-up visits.

Not a fit: Patients with distant metastases or recent active malignancy, severe uncontrolled comorbidities, major psychiatric or social barriers, inability to self-administer the intervention, or those outside the 20–70 age range may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could reduce post-radiotherapy vaginal symptoms and improve sexual function and quality of life for affected women.

How similar studies have performed: Related approaches such as vaginal moisturizers, dilator use, and pelvic floor rehabilitation have shown some benefit for post-radiotherapy vaginal symptoms, but CH2 gel specifically is relatively novel and less well studied.

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.

Where this trial is running

Taipei

• National Taiwan University Cancer Center — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD — National Taiwan University
• Study coordinator: Jenny Ling-Yu Chen Professor, Attending Physician, MD PhD

Conditions Gynecologic Malignancy; pelvic radiotherapy; CH2 vagina gel; vagina rehabilitation