Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Breast Carcinoma
- Cancer Survivor
- Cervical Carcinoma
- Dyspareunia
- Vaginal Dryness
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
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 wit...
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.
Tracking Information
- NCT #
- NCT03307044
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Allison Quick, MD Ohio State University Comprehensive Cancer Center