Promotion of Vaginal Health With CH2 Vaginal Gel After Pelvic Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CH2 vaginal gel, vaginal rehabilitation exercises.
- Who it may be relevant to
- Registry conditions: Gynecologic Malignancy. Basic parameters: 20 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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 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
- Other CH2 vaginal gel
12-week intervention with CH2 vaginal gel - Other vaginal rehabilitation exercises
12-week intervention with vaginal rehabilitation exercises
Primary outcome measures
- Female Sexual Function Index (FSFI) score [Time frame: From enrollment to the end of intervention at at 3, 6, and 12 months]
Eligibility criteria
Inclusion criteria
- Female patients aged between 20 and 70 years.
- Completion of pelvic radiotherapy for gynecologic cancer, which may include external beam radiotherapy (EBRT), brachytherapy (BT), or a combination of both.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Exclusion criteria
- Individuals under the age of 18.
- Presence of distant metastases or a history of malignancy currently under treatment within the past five years (excluding non-melanoma skin cancer).
- Presence of severe comorbidities, such as uncontrolled diabetes, cardiovascular disease, or autoimmune disorders that may interfere with treatment or study participation.
- Diagnosed psychiatric disorders or significant social factors that may prevent adherence to study requirements or completion of follow-up evaluations.
- Inability to self-administer vaginal gel or vaginal rehabilitation exercises.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- National Taiwan University Cancer Center — Taipei
Identifiers
NCT: NCT06997887 · 202503152RIPE