Comparing therapies for menopause symptoms in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: María Torres Lacomba, Full Professor
• Email: maria.torres@uah.es
• Phone: 34918854828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.