Other Clinical Trial - Evaluate Efficacy & Safety of LACUDY for Improving

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Breast Neoplasms
Hormone Receptor-positive Breast Cancer

Clinical Trial Details

NCT number	NCT05651087
Study type	Interventional
Source	Kyungpook National University Chilgok Hospital
Contact
Status	Not yet recruiting
Phase	N/A
Start date	December 20, 2022
Completion date	February 28, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms