Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Ohio State University Comprehensive Cancer Center66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Carcinoma Cancer Survivor Cervical Carcinoma Dyspareunia Vaginal Dryness

Interventions

Laser TherapyPROCEDURE

Undergo fractional CO2 laser therapy

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Change in Vaginal Assessment Scale score

Using Vaginal Assessment Scale (VAS)

Time frame: Baseline up to 4 weeks

Patient compliance rates

Compliance rates with treatment will be assessed.

Time frame: 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.

Time frame: Up to 4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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