Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Conditions
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Breast Carcinoma, Cancer Survivor, Cervical Carcinoma, Dyspareunia, Vaginal Dryness

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (fractional CO2 laser therapy)<br>Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments. | Procedure: Laser Therapy<br>* Undergo fractional CO2 laser therapy<br>* Other names: Therapy, Laser;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vaginal Assessment Scale score | Using Vaginal Assessment Scale (VAS) | Baseline up to 4 weeks | 
| Patient compliance rates | Compliance rates with treatment will be assessed. | Up to 4 weeks | 
| Feasibility of laser treatments defined by completion rates and tolerability of treatment | Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics. | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other symptoms of urogenital atrophy using the Urogenital Distress Inventory | Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemars Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary. | Up to 4 weeks | 
| Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare | Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemar?s Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary. | Up to 4 weeks |