Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
Primary Purpose
Hormone Receptor-positive Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LACUDY
Sponsored by
About this trial
This is an interventional treatment trial for Hormone Receptor-positive Breast Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Observation
Arm Description
Breast cancer patient who treated with LACUD
Breast cancer patient who does not treated with LACUD
Outcomes
Primary Outcome Measures
Change of Vaginal health index
Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
Secondary Outcome Measures
Vaginal microbiome
Take one cervicovaginal swab sample each
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05651087
Brief Title
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2022 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gun Oh Chong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Breast cancer patient who treated with LACUD
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Breast cancer patient who does not treated with LACUD
Intervention Type
Drug
Intervention Name(s)
LACUDY
Other Intervention Name(s)
IC-LC02S2Q2
Intervention Description
LACUDY:Insert 2mL twice a week for 4 weeks before going to bed
Primary Outcome Measure Information:
Title
Change of Vaginal health index
Description
Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
Time Frame
Prior to administration, 1 month after LacuD treatment(2 times in total)
Secondary Outcome Measure Information:
Title
Vaginal microbiome
Description
Take one cervicovaginal swab sample each
Time Frame
Prior to administration, 1 month after LacuD treatment(2 times in total)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
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