Breast Carcinoma Clinical Trial
Official title:
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Verified date | March 2023 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | May 5, 2022 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Vaginal Assessment Scale score | Using Vaginal Assessment Scale (VAS) | Baseline up to 4 weeks | |
Primary | Patient compliance rates | Compliance rates with treatment will be assessed. | Up to 4 weeks | |
Primary | 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 | 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 | |
Secondary | 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 |
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