Grant Number:	1R37CA316264-01 Interpret this number
Primary Investigator:	Rojas, Kristin
Organization:	University Of Tx Md Anderson Can Ctr
Project Title:	Standardizing Patient-Centered Treatment Protocols for Breast and Gynecologic Cancer Survivors with Sexual Dysfunction Incorporating Longitudinal Vaginal Microbiome Changes
Fiscal Year:	2026

PROJECT SUMMARY/ABSTRACT Sexual dysfunction affects >80% of female cancer survivors, yet fewer than half receive supportive care. Genitourinary Syndrome of Menopause (GSM), a constellation of vulvovaginal dryness, irritation, pain, and urinary symptoms caused by estrogen suppression, adversely impacts health-related quality of life (HRQoL) and may reduce adherence to endocrine therapy. GSM arises from ovarian insufficiency, structural mucosal changes, and shifts in the vaginal microbiome. The mechanism of genitourinary syndrome of menopause (GSM) related to breast cancer treatment is associated with changes in the vaginal microbiome through the depletion of vaginal epithelial glycogen, which limits the growth of beneficial Lactobacilli, and promotes harmful microbiota. Despite its prevalence, GSM remains underdiagnosed and undertreated. Our group has correlated genitourinary (GU) exam findings with validated patient-reported outcomes (PROs) and evaluated novel non-hormonal therapies in a Phase II trial, and found that disease site and hormone receptor-specific GSM treatment algorithms are associated with lower sexual distress and less sexual pain. Existing GSM treatment guidelines for oncology providers do not combine objective anatomic measures, PROs, and translational endpoints across diver survivors. We hypothesize that disease site-specific GSM treatment algorithms will reduce sexual distress compared to waitlist controls, with microbiome profiles predicting symptom severity and treatment response. Our study aims will: 1) evaluate tailored GSM treatment pathways in breast and/or gynecologic cancer survivors using the Vaginal Health Index (VHI) and patient-reported outcomes (VSQ, FSDS, FSFI); 2) identify vaginal microbial signatures of GSM severity and treatment response using shotgun metagenomics to report alpha and beta diversity, microbial composition, and functional shifts; and 3) assess barriers, facilitators, and outcomes impacting implementation using CFIR-guided mixed methods to inform scalability. Our team’s multidisciplinary expertise and robust preliminary data position us to establish the first integrated, biomarker-informed, patient-centered pathways for GSM treatment in female cancer survivors. This work will enable precision survivorship care, identify predictive biomarkers, and create scalable care pathways to improve quality of life, cancer treatment adherence, and potentially oncologic outcomes.





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