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New treatment option for Breast Cancer Female
Official title Lactobacillus Vaginalis Capsules for Treatment of Vulvovaginal Atrophy in Young Breast Cancer Patients
ClinicalTrials.gov ID: NCT05974449
What this study is testing
What is Vaginal Lactobacillus capsules?
Vaginal Lactobacillus capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer female.
Also referred to as Ding Jun Sheng.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join 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...
- Pre-menopausal (including perimenopausal);
- Good compliance, normal comprehension and ability to receive treatment as required;
You likely can't join 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...
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.