In short
This article discusses a clinical trial investigating the use of Lactobacillus Acidophilus, Lyophilized, along with other treatments, for vulvovaginal atrophy in breast cancer patients undergoing endocrine therapy. The study aims to evaluate the effectiveness and safety of different treatment regimens, including a combination of estriol and Lactobacillus Acidophilus, to address symptoms such as dryness, irritation, and pain during intercourse.
At a glance
- Study Type
- Phase IV Clinical Trial, active-controlled, randomized
- Condition
- Vulvovaginal atrophy in breast cancer patients on endocrine therapy
- Main Treatment
- Gynoflor (containing Lactobacillus Acidophilus, Lyophilized and Estriol)
- Other Treatments
- Oekolp, Intratose, Premeno Duo
- Treatment Duration
- 12 weeks
- Primary Outcomes
- Efficacy (patient-reported outcomes) and Safety (hormone levels)
- Secondary Outcome
- Identification of microbial alterations after treatment
- Inclusion Criteria
- Postmenopausal breast cancer patients on endocrine therapy with symptoms of vulvovaginal atrophy
- Exclusion Criteria
- History of vulvar/vaginal surgery, current vulvar/vaginal disease, recent antibiotic use, current use of vaginal hormonal treatment
What is Lactobacillus Acidophilus?
Lactobacillus acidophilus is a type of beneficial bacteria, also known as a probiotic. In this context, it is being studied as part of a treatment for a condition called vulvovaginal atrophy in breast cancer patients. The medication being investigated contains lyophilized (freeze-dried) Lactobacillus acidophilus, which means the bacteria are preserved in a way that keeps them viable for use in the vaginal tablets.
Medical Condition and Treatment
The clinical trial is focusing on vulvovaginal atrophy in breast cancer patients who are undergoing endocrine therapy. Vulvovaginal atrophy is a condition where the vaginal tissues become thin, dry, and inflamed due to a lack of estrogen. This can cause symptoms such as vaginal dryness, irritation, and pain during intercourse (dyspareunia).
The treatment being studied is called Gynoflor, which is a combination of two active ingredients:
- Estriol: A form of estrogen
- Lactobacillus acidophilus: A probiotic bacteria
This combination is designed to help improve the health of the vaginal tissues and restore the natural balance of bacteria in the vagina.
Clinical Trial Details
The clinical trial is called the GRACE trial (vulvovaGinal atRophy in breAst Cancer patients on Endocrine therapy). It is a Phase IV clinical trial, which means it is studying an already approved medication to gather more information about its effectiveness and safety in a specific group of patients.
Treatment Regimen
The Gynoflor treatment in this study follows this schedule:
- One vaginal tablet daily for twelve consecutive days
- Followed by one vaginal tablet twice per week
This regimen is designed to first intensively treat the symptoms and then maintain the improvements with less frequent use.
Eligibility Criteria
To participate in this study, patients must meet certain criteria:
Inclusion Criteria:
- Have breast cancer
- Be currently on endocrine therapy (AI or SERM)
- Be postmenopausal (defined by specific criteria)
- Have one or more symptoms of vulvovaginal atrophy (such as pain during intercourse, dryness, or irritation)
Exclusion Criteria:
- History of vulvar or vaginal surgery
- Current other vulvar or vaginal diseases
- Recent use of antibiotics, antifungals, or corticosteroids (within the last month)
- Current use of vaginal hormonal treatment or vaginal moisturizer (unless stopped for 4 weeks before the study)
These criteria help ensure that the study focuses on the right group of patients and minimizes factors that could interfere with the results.
Study Objectives
The main goals of this study are:
- Efficacy assessment: The researchers want to see how well the treatment works. They will use questionnaires that patients fill out (called Patient-Reported Outcome Measures or PROMs) and clinical evaluations like checking vaginal pH and examining vaginal cells under a microscope.
- Safety assessment: The study will check if the treatment is safe for breast cancer patients. They will do this by measuring sex hormone levels in the blood.
- Microbiome study: The researchers will also look at how the treatment changes the types of bacteria in the vagina. This could help understand more about vulvovaginal atrophy and potentially lead to new treatment ideas.
Safety Considerations
Safety is a key concern in this study, especially because the participants are breast cancer patients. The researchers will carefully monitor the levels of sex hormones in the blood to ensure the treatment doesn't cause any unwanted effects related to hormone levels. This is particularly important because many breast cancers are sensitive to hormones.
It's important to note that while previous research has not shown an increased risk of breast cancer recurrence with this type of treatment, this study aims to provide more direct comparative data on the safety of different treatment options.