NCT06721936 Genitourinary Syndrome of Menopause in Breast Cancer
| NCT ID | NCT06721936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alcala |
| Condition | Genitourinary Syndrome of Menopause (GSM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2024-11-29 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2024-11-29 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized, single-blind clinical trial will compare the effectiveness of multimodal pelvic floor physiotherapy (PPT) and fractional CO2 vaginal laser therapy in reducing genitourinary syndrome of menopause (GSM) symptoms among breast cancer (BC) survivors. GSM, induced by cancer treatments, is common in BC survivors due to hormonal deprivation, and effective non-hormonal treatments are needed. The study will enroll 210 women diagnosed with GSM following BC treatment, who will be randomly assigned to either three sessions of CO2 vaginal laser therapy or eight sessions of multimodal PPT, which includes pelvic floor muscle training, vaginal non-ablative radiofrequency, education, and moisturizers. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL), with assessments at baseline, post-intervention, and at 3, 6, and 12 months. The hypothesis is that multimodal PPT will lead to greater improvements in pelvic pain, muscle function, and sexual health, with sustained benefits over time. This trial aims to provide evidence for non-invasive, non-hormonal treatments to manage GSM in BC survivors, filling a significant therapeutic gap.
Eligibility Criteria
Inclusion Criteria: * Breast cancer survivors diagnosed with GSM as a result of cancer treatment * Vaginal Health Index (VHI) score of ≤ 15. Exclusion Criteria: * History of conservative treatment or surgery for pelvic floor dysfunction or GSM * Currently undergoing chemotherapy, or have undergone BC surgery but have not received chemotherapy or hormonal treatment. * Presence of concomitant or systemic diseases that could interfere with the proposed treatments, such as a recurrence of the oncological process, active or recurrent untreated urinary tract infections, hematuria, or cognitive impairments that hinder the participant's ability to comprehend study information, respond to questionnaires, provide informed consent, or fully participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06721936 clinical trial?
This trial is open to female participants only, aged 38 Years or older, studying Genitourinary Syndrome of Menopause (GSM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06721936 currently recruiting?
Yes, NCT06721936 is actively recruiting participants. Contact the research team at maria.torres@uah.es for enrollment information.
Where is the NCT06721936 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06721936 clinical trial?
NCT06721936 is sponsored by University of Alcala. The trial plans to enroll 182 participants.