Gynecologic Malignancy
Conditions
Keywords
pelvic radiotherapy, CH2 vagina gel, vagina rehabilitation
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.
Detailed description
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.
Interventions
OTHERCH2 vaginal gel
12-week intervention with CH2 vaginal gel
OTHERvaginal rehabilitation exercises
12-week intervention with vaginal rehabilitation exercises
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will undergo a 12-week intervention with either CH2 vaginal gel or vaginal rehabilitation exercises.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) score | From enrollment to the end of intervention at at 3, 6, and 12 months | 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. |
Countries
Taiwan
Contacts
Primary ContactJenny Ling-Yu Chen Professor, Attending Physician, MD PhD
Outcome results
None listed