Fractional CO2 Laser No Better Than Sham for GSM in Breast Cancer Survivors

Fractional carbon dioxide (CO2) laser therapy did not outperform a sham procedure on sexual or vaginal health at 12 months in breast cancer survivors with genitourinary syndrome of menopause (GSM) receiving aromatase inhibitors, according to a secondary analysis of a randomized clinical trial published in JAMA Network Open.

Use of laser therapy for GSM in breast cancer survivors has grown despite limited sham-controlled evidence, the investigators noted. This exploratory analysis reported 12-month outcomes from the single-center, double-blind, sham-controlled LIGHT trial (NCT04619485), conducted at a tertiary academic hospital in Spain.

The trial randomly assigned 84 participants with GSM and dyspareunia (mean age, 53.8 years) to 5 monthly sessions of fractional CO2 laser or sham laser; all participants also received first-line nonhormonal therapy, including vaginal moisturizers and vibrators. Of these, 67 completed 12-month follow-up. Among sexually active participants, the change in Female Sexual Function Index (FSFI) score from baseline to 12 months did not differ between groups (difference, −0.69; 95% CI, −3.58 to 2.20). No between-group differences emerged for any secondary outcome, including dyspareunia, Vaginal Health Index, and objective vaginal measures.

Across the full cohort, mean FSFI scores improved from 18.9 at baseline to 23.0 at 12 months, and dyspareunia, body image, and Vaginal Health Index scores also improved. At 12 months, 57 of 67 participants (85.1%) were sexually active. Adherence to first-line therapy was similar between groups. No severe adverse events occurred; 3 urinary tract infections were reported between the 6- and 12-month visits.

According to the investigators, gains in both arms likely stemmed from first-line therapy adherence, trial participation, or contextual factors rather than from laser efficacy. They said high-quality sham-controlled trials are still needed before routine use. Limitations they noted included the single-center design, enrollment of aromatase inhibitor users only, and possible underpowering for objective measures due to 12-month biopsy refusals.

Source: Anglès-Acedo S, Alonso I, Ribera-Torres L, et al. Laser therapy for sexual health in breast cancer survivors receiving aromatase inhibitors: a secondary analysis of a randomized clinical trial. JAMA Netw Open. 2026;9(10):e2638937. doi:10.1001/jamanetworkopen.2026.38937