NCT03307044

Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment. II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS). SECONDARY OBJECTIVES: I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS). II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI). III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale (PGI-I). OUTLINE: Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments. After completion of study treatment, patients are followed up at 4 weeks.

Conditions

• Breast Carcinoma
• Cancer Survivor
• Cervical Carcinoma
• Dyspareunia
• Vaginal Dryness

Interventions

Type	Name	Description
PROCEDURE	Laser Therapy	Undergo fractional CO2 laser therapy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-11-16
• Primary completion: 2018-12-21
• Completion: 2022-05-05
• First posted: 2017-10-11
• Last updated: 2023-03-20

Locations

1 site across 1 country: United States