Vitamin D treatment for genitourinary syndrome of menopause (GSM) symptoms in postmenopausal women with breast cancer Urological and Genital Diseases
Conditions
Interventions
Postmenopausal women, aged 20-80 years old, diagnosed with breast cancer and treated with aromatase inhibitors or GnRH agonists for more than 12 weeks, who present with bothersome vaginal symptoms (de
Sponsors
Khon Kaen University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Breast cancer 2. Treated with aromatase inhibitors or GnRH agonists for longer than 12 weeks 3. Aged 20-80 years old 4. Menopause (defined as no menstruation in the past 12 months) 5. Presented with most bothersome vaginal symptoms (defined as the visual analog scores >= 4 scores by interview) 6. Serum total vitamin D < 30 ng/ml 7. Willing to participate with signed informed consent
Exclusion criteria
Exclusion criteria: 1. History of hormonal use or vitamin D supplement within 12 weeks 2. Recurrent breast cancer 3. History of procedure or vaginal product use within 12 weeks 4. History of vulvovaginal infection within 12 weeks 5. History of abnormal PAP smear 6. History of vitamin D allergy 7. History of intestinal disease 8. Active hepatic disease 9. Impair renal function (GFR < 60 ml/min/1.73m2) 10. Refused to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bothersome vaginal symptoms of GSM measured using a visual analog scale (VAS) at baseline, 6, and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and 12 weeks: 1. Vaginal health index (VHI) measured using a vaginal health index (VHI) score 2. Vaginal Maturation Index measured using a vaginal maturation index (VMI) score 3. Vaginal pH measured using pH paper 4. Serum vitamin D level measured using blood specimen analyzed by electrochemiluminescence binding assay | — |
Countries
Thailand
Contacts
Public ContactSuppakan Preetikul
Outcome results
None listed