Actively Recruiting
Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-12-12
60
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed invasive breast cancer
- Female patients aged 18 to 40 years with any hormone receptor status, or 41 to 45 years with negative hormone receptor status
- Expected to receive 4 or more chemotherapy cycles containing paclitaxel or anthracycline plus ovarian protective drugs
- Pre-menopausal or perimenopausal status
- Good treatment compliance and ability to understand study requirements
- ECOG performance status of 0 or 1
- Volunteered and signed informed consent form
You will not qualify if you...
- Use of any vaginal medication within 3 months prior to study
- Use of any anti-infective medication within 3 months prior to study
- Active genital tract infection
- Previous diagnosis of other malignancies
- Unable to complete full follow-up treatment as prescribed
- Abnormal liver or kidney function tests beyond defined limits
- Left ventricular ejection fraction less than 50%
- Severe coagulation disorders, severe systemic disease, or uncontrolled infection
- Lack of personal freedom or legal capacity, presence of mental disorders or addictions deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
R
Ran Zheng
CONTACT
J
Jue Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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