Breast Cancer, Vaginal Atrophy
Conditions
Keywords
chemotherapy, hormonal therapy, urogenital atrophy
Brief summary
1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life. 2. Clino-san is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks. 3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.
Interventions
DRUGclino-san vaginal lubricant
Clino-san 2ml vaginal application 3 times per week for 12 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* breast cancer patients * who are treated with chemotherapy or hormonal therapy * who experience no menstruation after the previous therapy * who complain of vaginal dryness
Exclusion criteria
* other cancer patients * other severe disease * poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal dryness score | for 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| sexual dysfunction | for 12 weeks |
Countries
South Korea
Outcome results
None listed