Clinical trial · Interventional
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LACUDY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Breast cancer patient who treated with LACUD
- interventionNames
- Drug: LACUDY
- type
- NO_INTERVENTION
- label
- Observation
- description
- Breast cancer patient who does not treated with LACUD
Primary outcomes (1)
- measure
- Change of Vaginal health index
- timeFrame
- Prior to administration, 1 month after LacuD treatment(2 times in total)
- description
- Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female 2. Aged 20 to 60 years diagnosed with breast cancer 3. Receiving anti-hormonal therapy 4. Patients who subjectively complain of vaginal dryness 5. Patients without current psychiatric problems 6. Patients who can understand and respond to the contents of the questionnaire 7. Ability to provide informed consent Exclusion Criteria: 1. Women under 19 and over 61 2. Pregnant woman 3. In case of recurrence or disease progression 4. Patients without sexual experience 5. Unable to provide informed consent
References
Publications (0)
Data not yet available