Comparing therapies for menopause symptoms in breast cancer survivors
Genitourinary Syndrome of Menopause Induced by Breast Cancer Treatments: A Randomized Clinical Trial Protocol Comparing Multimodal Pelvic Floor Physiotherapy and Frac-tional CO2 Laser Therapy (PILME Study).
This study is testing two non-hormonal treatments to see which one helps breast cancer survivors with menopause symptoms like pain and sexual function better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 38 Years and up |
| Sex | Female |
| Sponsor | University of Alcala Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06721936 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two non-hormonal treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors. Participants will be randomly assigned to receive either multimodal pelvic floor physiotherapy or fractional CO2 vaginal laser therapy. The study will enroll 210 women diagnosed with GSM and assess outcomes such as perineal pain, sexual function, and health-related quality of life at multiple time points. A cost-effectiveness analysis will also be conducted to compare the interventions.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors diagnosed with GSM following their cancer treatment.
Not a fit: Patients currently undergoing chemotherapy or those with a history of pelvic floor dysfunction treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-hormonal treatment options for breast cancer survivors suffering from GSM.
How similar studies have performed: While similar approaches have been explored, this specific comparison of multimodal physiotherapy and laser therapy in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: María Torres Lacomba, Full Professor
- Email: maria.torres@uah.es
- Phone: 34918854828
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.