Status:
COMPLETED
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Breast Carcinoma
Cancer Survivor
Eligibility:
FEMALE
Phase:
NA
Brief 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 o...
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 tolerabili...
Eligibility Criteria
Inclusion
- Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
- Symptoms of urogenital atrophy including dyspareunia or vaginal dryness
Exclusion
- Patients with metastatic breast cancer
- Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
- Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
- Pelvic organ prolapse greater than stage II
- Prior reconstructive pelvic surgery involving mesh
- Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03307044
Start Date
November 16 2017
End Date
May 5 2022
Last Update
March 20 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210