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Not Yet Recruiting NCT05651087

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

Conditions: Hormone Receptor-positive Breast Cancer

Sex: Female
Ages: 20 Years – 60 Years
Phase: NA
Enrollment: 60
Sponsor: Gun Oh Chong

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.

Eligibility Criteria

Inclusion Criteria:FemaleAged 20 to 60 years diagnosed with breast cancerReceiving anti-hormonal therapyPatients who subjectively complain of vaginal drynessPatients without current psychiatric problemsPatients who can understand and respond to the contents of the questionnaireAbility to provide informed consentExclusion Criteria:Women under 19 and over 61Pregnant womanIn case of recurrence or disease progressionPatients without sexual experienceUnable to provide informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05651087). StuddyBuddy aggregates publicly available trial information.