New treatment for breast cancer survivors with menopause-related symptoms
A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
This study is testing if platelet-rich plasma injections can help breast cancer survivors with menopause-related vaginal symptoms feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05812924 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of platelet-rich plasma (PRP) injections in alleviating symptoms of genitourinary syndrome of menopause (GSM) in female breast cancer survivors. Participants will include women aged 18 and older who have a history of breast cancer and a vaginal health index score indicating GSM. The study will assess improvements in vaginal health following PRP treatment, which is a novel approach for this patient population. The trial is interventional and is currently in Phase 2.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer survivors aged 18 and older with a history of DCIS or Stage I-III breast cancer and a vaginal health index score of less than 15.
Not a fit: Patients who do not have a history of breast cancer or those with a vaginal health index score of 15 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for breast cancer survivors experiencing menopause-related symptoms.
How similar studies have performed: While this specific approach using PRP for GSM in breast cancer survivors is novel, similar studies using PRP for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients who are age 18 years and older * Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment. * Patients must be found to have a vaginal health index (VHI) score of \<15. * Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled. * Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate. * Patients must provide written informed consent for participation in this study. * Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed. Exclusion Criteria: * Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded. * Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Kristin E Rojas, MD — University of Miami
- Study coordinator: Kristin E. Rojas, MD
- Email: krojas@med.miami.edu
- Phone: 305-243-1450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.