Radiation vaginitis in cervical cancer patients Radiation vaginitis Cervical cancer Gynoflor
Conditions
Interventions
A vaginal tablet containing 0.03 mg of Estriol and 100 million viable Lactobacillus acidophilus
Dosing: initial therapy of 14 daily dose followed by maintenance therapy of one tablet for two days per
Experimental Drug,Active Comparator Drug
Gynoflor,Regelle
Sponsors
Songklanagarind Hospital
Eligibility
Sex/Gender
Female
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Stage I to Stage III (according to FIGO staging 2018) cervical cancer patients who completed radiotherapy treatment within 3-6 months 2. Thai ethnicity 3. Experiencing vaginal toxicities symptoms which affect quality of life
Exclusion criteria
Exclusion criteria: 1. Current severe vaginal infection 2. Current contact allergy in vulvovaginal area 3. Genital structure abnormality 4. Use of other vaginal route drugs within 2 weeks 5. Use of other hormonal therapy within 3 months 6. Hypersensitivity to Gynoflor composition both active and inactive ingredients 7. Existing or suspected estrogen-dependent tumors in the breast, uterus, or ovaries 8. Vaginal bleeding of unknown origin 9. Recurrent or progressive disease 10. Patients with contraindication for using estrogen i.e. DVT VTE SLE with positive APS antibodies or other vascular diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal maturation value At baseline, 1 month after exposure Collecting vaginal smear and calculated by using formula including number of parabasal cell, intermediate cells and superficial cell. (0x%parabasal cells + 0.5x%intermediary cell+1x%superficial cells) | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal toxicities At baseline, 2 weeks after exposure, 1 month after exposure Using questionnaire to rate the severity of each vaginal toxicity symptos according to CTCAE version 5.0 (including vaginal inflammation, dyspareunia, discharge, pain and dryness),Vaginal pH At baseline, 1 month after exposure Apply nitrazine pH indicator at lateral vaginal at outer one-third of vagina. Value more than 4.5 indicates low estrogen level,Female sexual function index At baseline, 2 weeks after exposure, 1 month after exposure Questionnaire with 5 domains about sexual health questions | — |
Countries
Thailand
Contacts
Public ContactNatcha Koohachaiskun
Songklanagarind Hospital
Outcome results
None listed