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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hormone Receptor-positive Breast Cancer
• Intervention / Treatment: Drug: LACUDY

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Gun Oh Chong

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LACUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No