Women With Breast Cancer
Conditions
Keywords
genitourinary syndrome, prasterone, breast cancer
Brief summary
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
Interventions
Prasterone 6.5 mg vaginal tablets
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed breast cancer, completely excised * Natural or iatrogenic menopausal status * No evidence of distant metastasis * Self-identified moderate to severe symptoms of genitourinary syndrome * Normal kidney and liver function * Written Informed Consent signed and dated by patient * Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment
Exclusion criteria
* Vaginal or uterine bleeding of unknown origin * Current diagnosis of any non-breast malignancy * Metastatic disease * Currently on chemiotherapy * Currently on treatment with tamoxifen * Mentally incompetent or evidence of active substance or alcohol abuse * Endometrial hyperplasia * Pregnancy or lactation * Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit) * Clinically significant metabolic or endocrine disease not controlled by medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish subjective improvement in genitourinary symptomatology at intervals marked by the study | From enrollment to after 3 months after the end of treatment | To establish the improvement in vulvovaginal and urinary symptoms, by subjective evaluation at baseline, at 12 weeks and after 1 and 3 months after the end of the treatment. Establish tissue trophism improvement through gynecological evaluation, the use of validated scales (Vaginal Health Index), and determination of the maturation index on vaginal spatula, measure serum estradiol during and after treatment |
| evaluation of vulvovaginal and urinary symptoms | 6 months | evaluation of vaginal dryness, dyspareunia, pruritis, burning and dysuria with a 0 to 4 score (0: absence, 1: mild, 2: moderate, 3: severe, 4: very severe) |
| improvement in vaginal signs | 6 months | To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI) |
| evaluation fo maturation index | 6 months | To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa |
| grade of satisfaction | 6 months | To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study |
Countries
Italy
Contacts
Primary ContactSILVIA MARTELLA
Outcome results
None listed