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

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gun Oh Chong

Criteria

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