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

Hormone Receptor-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651087
• Other study ID #: LACUDY
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2022
• Source: Kyungpook National University Chilgok Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor-positive Breast Cancer

Intervention

Drug:
• LACUDY
LACUDY:Insert 2mL twice a week for 4 weeks before going to bed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gun Oh Chong

Outcome

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