Evaluate Efficacy and Safety of LACUDY for Improving Vagi... | NCT05651087

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

NCT05651087

Sponsor

Gun Oh Chong

Status

Unknown status

Last Update Posted

Dec 14, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hormone Receptor-positive Breast Cancer

Interventions

LACUDY

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2022Estimated

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

Nov 8, 2022

First Submission Date that Met QC Criteria

Dec 6, 2022

First Posted Date

Dec 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2022

Last Update Posted Date

Dec 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gun Oh Chong, professor, Kyungpook National University Chilgok HospitalSponsor-Investigator

Lead Sponsor

Gun Oh ChongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Breast cancer patient who treated with LACUD	Drug: LACUDY
Observation	No Intervention	Breast cancer patient who does not treated with LACUD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LACUDY	Drug	LACUDY:Insert 2mL twice a week for 4 weeks before going to bed	Experimental

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided