RecruitingPhase 2NCT05974449

Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients

A Phase II Clinical Study of Lactobacillus Vaginalis Capsules for the Prevention and Treatment of Symptoms of Vulvovaginal Atrophy in Young Breast Cancer Patients Receving Ovarian Function Suppression (OFS) During Chemotherapy


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

60 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, randomized controlled, phase II clinical study with a planned enrolment of 60 patients. The study focuses on the efficacy and safety of Lactobacillus vaginalis capsules for the prevention and/or treatment of vulvovaginal symptoms in young breast cancer patients receiving ovarian protection during chemotherapy, in order to improve compliance and quality of life in breast cancer patients.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vaginal Lactobacillus capsules (a probiotic inserted into the vagina) can help young breast cancer patients who experience vaginal dryness and discomfort during chemotherapy. The treatment aims to restore healthy vaginal bacteria. **You may be eligible if...** - You are a woman aged 18–40 with breast cancer (any type), OR aged 41–45 with hormone receptor-negative breast cancer - You are pre-menopausal or perimenopausal - You are planned to receive at least 4 cycles of chemotherapy containing paclitaxel or anthracycline **You may NOT be eligible if...** - You have used vaginal medication or anti-infective drugs in the past 3 months - You have an active genital tract infection - You have a known allergy to probiotics or related ingredients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVaginal Lactobacillus capsules

This product is a micro-ecological preparation made from live Lactobacillus and is used for the treatment of vaginosis caused by disorders of the flora.


Locations(1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05974449


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