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

NCT05974449 | Recruiting Phase 2

• 1 other identifier: BC-OFSAE-Lactobacillus
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Female

Keywords

Breast cancer, Vulvovaginal symptoms ，Lactobacillus capsules

Outcome Measures

Primary Outcomes (2)

• Vaginal PH

  Reactive vaginal pH

  1 year

• Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

  For assessing quality of life and vulvovaginal symptoms in women. Using "Absolutely not", "A little", "Some", "Very", "Extremely" to indicate the severity of symptoms

  1year

Secondary Outcomes (2)

• The detection rate of vaginal secretions of Gardnerella vaginalis, Lactobacillus janus, Lactobacillus garciae, Lactobacillus curvatus, Lactobacillus inertus, Lactobacillus chimaerae, Prevotella spp. and Streptococcus spp;

  1year

• Serum concentrations of estrone, estradiol and oestrogen binding protein

  1 year

Study Arms (2)

C1, C2 dosing group

EXPERIMENTAL

C1 and C2 dosing groups: The drug is administered on the day of the C1 and C2 chemotherapy cycles for 10 days, washing the vulva and placing the drug deep into the vagina, once a night, 1 capsules each time.

Drug: Vaginal Lactobacillus capsules

C3, C4 dosing group

EXPERIMENTAL

C3 and C4 dosing groups: The drug is given on the day of the C3 and C4 chemotherapy cycles and is administered for 10 days. The drug is placed deep into the vagina after washing the vulva, once a night, 1 capsules each time.

Drug: Vaginal Lactobacillus capsules

Interventions

Vaginal Lactobacillus capsules DRUG

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.

Also known as: Ding Jun Sheng

C1, C2 dosing group; C3, C4 dosing group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Use of any other vaginal medication in the 3 months prior to the study;
• Use of any anti-infective medication in the 3 months prior to the study;
• Active genital tract infection;
• Previous development of other malignancies;
• Any reason why they are unable to complete the full course of follow-up treatment as prescribed by their doctors;
• 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;
• Severe coagulation disorder, severe systemic disease, or uncontrollable infection;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jue Wang, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Ran Zheng

CONTACT

008615705227155; 15705227155@163.com

Jue Wang, MD

CONTACT

008618061695508; wangjue200011@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: August 24, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)