Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient

Study Overview
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Brief Summary
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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.

Detailed Description
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Registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). Experimental group with 30 patients and Control group with 30 patinets. In the case of the experimental group, LACUDY 2mL is inserted twice a week for a month before going to bed for 4 weeks. Unpack the product and take it out. Remove the cap by turning it. Fit the nozzle to the end of the syringe and turn it to combine. Hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina. Slowly remove the syringe as the nozzle opens. It is recommended to wear a pad as the injected solution may flow out. In the case of the control group, they go about their daily lives without any treatment. Both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement. A total of 2 questionnaires were conducted before and after treatment.

Official Title
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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

Conditions
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Hormone Receptor-positive Breast Cancer

Intervention / Treatment
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* Drug: LACUDY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 20 to 60 years diagnosed with breast cancer Receiving anti-hormonal therapy Patients who subjectively complain of vaginal dryness Patients without current psychiatric problems Patients who can understand and respond to the contents of the questionnaire Ability to provide informed consent Exclusion Criteria: Women under 19 and over 61 Pregnant woman In case of recurrence or disease progression Patients without sexual experience Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Breast cancer patient who treated with LACUD | Drug: LACUDY<br>* LACUDY:Insert 2mL twice a week for 4 weeks before going to bed<br>* Other names: IC-LC02S2Q2;|
| No Intervention: Observation<br>Breast cancer patient who does not treated with LACUD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Vaginal health index | Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B) | Prior to administration, 1 month after LacuD treatment(2 times in total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal microbiome | Take one cervicovaginal swab sample each | Prior to administration, 1 month after LacuD treatment(2 times in total) |