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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies

Conditions
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Cervical Carcinoma, Dyspareunia, Endometrial Carcinoma, Ovarian Carcinoma, Vaginal Carcinoma, Vaginal Dryness, Vulvar Carcinoma

Intervention / Treatment
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* Procedure: Laser Therapy
* Other: Questionnaire Administration
* Procedure: Sham Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment Any form of hysterectomy, including radical hysterectomy permitted Must have no evidence of recurrent disease on pelvic exam within past 3 months Radiation therapy is permitted but not required Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain Exclusion Criteria: Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer Pelvic organ prolapse stage II or higher Prior reconstructive pelvic surgery involving mesh Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (fractional CO2 laser therapy)<br>Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart. | Procedure: Laser Therapy<br>* Undergo fractional CO2 laser therapy<br>* Other names: Therapy, Laser;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Sham Comparator: Arm II (sham laser therapy)<br>Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I. | Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Sham Intervention<br>* Undergo sham laser therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in genitourinary syndrome of menopause (GSM) symptoms | Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by number of patients able to complete 3 study visitis | A crossover design to determine the feasibility of the crossover design for potential use in a phase III trial by summarizing the proportion of patients who are unable to tolerate the study treatment prior to completing the 3 treatments | Up to 1 month | 
| Improvement in objective findings of vaginal atrophy | Will determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment. | Up to 1 month | 
| Improvement in sexual function by FSFI | Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI) | Up to 1 year | 
| Improvement in sexual function FSDS | Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS) | Up to 1 year | 
| Improvement in urinary symptoms | Will determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI). The change in dyspareunia and dryness between baseline (T0) and T4 will be calculated and compared between the treatment and sham arms using a two sample t-test or Wilcoxon rank sum test. | Up to 1 month | 
| Incidence of adverse events | Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) | Up to 1 month | 
| Number of patients complete all treatments | Summarize the proportion of patients who are able to tolerate the study treatment and complete the 3 treatments. | Up to 1 month | 
| Satisfaction with vaginal fractional CO2 laser therapy | Patients will be asked to rate their satisfaction with the procedure on a likert-type scale of 1-10 with 1 being completely dissatisfied and 10 being extremely satisfied. Participants will be asked to rate their satisfaction on this scale after each treatment and at follow-up. | Up to 1 month |