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

Sponsor
Gun Oh Chong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05651087
Collaborator
(none)
60
Enrollment
2
Arms
2.3
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change of Vaginal health index [Prior to administration, 1 month after LacuD treatment(2 times in total)]

      Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)

    Secondary Outcome Measures

    1. Vaginal microbiome [Prior to administration, 1 month after LacuD treatment(2 times in total)]

      Take one cervicovaginal swab sample each

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gun Oh Chong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gun Oh Chong, professor, Kyungpook National University Chilgok Hospital
    ClinicalTrials.gov Identifier:
    NCT05651087
    Other Study ID Numbers:
    • LACUDY
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Dec 14, 2022