Effects of Gynoflor in reducing radiation vaginitis in cervical cancer patients

Phase 3

• Conditions: Radiation vaginitis in cervical cancer patients; Radiation vaginitis; Cervical cancer; Gynoflor

• Registration Number: TCTR20240510001
• Lead Sponsor: Songklanagarind Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Last Update Posted: 19 August 2024
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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),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

Secondary Outcome Measures

Name	Time	Method
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)