Lactobacillus capsules for treating vaginal symptoms 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

This study is testing if Lactobacillus capsules can help young breast cancer patients who are getting chemotherapy feel better by reducing vaginal dryness and discomfort.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05974449 on ClinicalTrials.gov

What this trial studies

This phase II clinical study investigates the efficacy and safety of Lactobacillus vaginalis capsules in alleviating vulvovaginal symptoms in young breast cancer patients undergoing chemotherapy. The study aims to enroll 60 patients who are receiving ovarian protection during their treatment. By addressing issues such as vaginal dryness and discomfort, the study seeks to improve the quality of life and treatment compliance for these patients. Participants will be monitored for their response to the treatment and any associated side effects.

Who should consider this trial

Good fit: Ideal candidates are pre-menopausal female patients aged 18-45 with invasive breast cancer who are expected to undergo chemotherapy.

Not a fit: Patients with active genital tract infections or those who have used other vaginal medications recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for young breast cancer patients experiencing vulvovaginal symptoms due to chemotherapy.

How similar studies have performed: While the use of Lactobacillus for vaginal health is established, this specific application in young breast cancer patients undergoing chemotherapy is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Pathologically confirmed invasive breast cancer (regardless of pathology type);
2. Female patients 18-40 years of age with unlimited HR, or 41-45 years of age with negative HR;
3. Patients expected to receive ≥4 cycles of chemotherapy containing paclitaxel or anthracycline-containing chemotherapeutic agents and ovarian protective drugs;
4. Pre-menopausal (including perimenopausal);
5. Good compliance, normal comprehension and ability to receive treatment as required;
6. ECOG score 0-1;
7. Patients volunteered to participate in this study and signed an informed consent form.

Exclusion Criteria:

1. Use of any other vaginal medication in the 3 months prior to the study;
2. Use of any anti-infective medication in the 3 months prior to the study;
3. Active genital tract infection;
4. Previous development of other malignancies;
5. Any reason why they are unable to complete the full course of follow-up treatment as prescribed by their doctors;
6. AST and ALT ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; LVEF \< 50% on cardiac ultrasound;
7. Severe coagulation disorder, severe systemic disease, or uncontrollable infection;
8. Persons without personal freedom and independent civil capacity; the presence of mental disorders, addictions, etc., which in the judgment of the investigator do not qualify for enrolment.

Where this trial is running

Nanjing, Jiangsu

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ran Zheng

Conditions Breast Cancer Female; Breast cancer, Vulvovaginal symptoms ，Lactobacillus capsules