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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedStudy Start
First participant enrolled
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedDecember 14, 2022
December 1, 2022
2 months
November 8, 2022
December 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Vaginal microbiome
Prior to administration, 1 month after LacuD treatment(2 times in total)
Study Arms (2)
Experimental
EXPERIMENTALBreast cancer patient who treated with LACUD
Observation
NO INTERVENTIONBreast cancer patient who does not treated with LACUD
Interventions
LACUDY:Insert 2mL twice a week for 4 weeks before going to bed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women under 19 and over 61
- Pregnant woman
- In case of recurrence or disease progression
- Patients without sexual experience
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gun Oh Chonglead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 8, 2022
First Posted
December 14, 2022
Study Start
December 20, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
December 14, 2022
Record last verified: 2022-12