NCT03372720

Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors

Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.

Detailed description

PRIMARY OBJECTIVES: I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS). SECONDARY OBJECTIVES: I. To evaluate toxicity associated with vaginal laser therapy in this population. II. To determine how many women with the defined patient eligibility will complete all treatments. III. To determine the feasibility of the crossover design for potential use in a phase III trial. IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment. V. To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment. VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI). VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy. OUTLINE: Patients are randomized in to 1 of 2 arms. ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart. ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I. After completion of study, patients are followed up at 1 month.

Conditions

• Cervical Carcinoma
• Dyspareunia
• Endometrial Carcinoma
• Ovarian Carcinoma
• Vaginal Carcinoma
• Vaginal Dryness
• Vulvar Carcinoma

Interventions

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

Timeline

• Start date: 2018-05-11
• Primary completion: 2019-12-18
• Completion: 2022-04-12
• First posted: 2017-12-14
• Last updated: 2022-04-22

Locations

4 sites across 1 country: United States