Breast Carcinoma, Cancer Survivor, Cervical Carcinoma, Dyspareunia, Vaginal Dryness
Conditions
Brief summary
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
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.
Interventions
PROCEDURELaser Therapy
Undergo fractional CO2 laser therapy
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal Assessment Scale score | Baseline up to 4 weeks | Using Vaginal Assessment Scale (VAS) |
| Patient compliance rates | Up to 4 weeks | Compliance rates with treatment will be assessed. |
| Feasibility of laser treatments defined by completion rates and tolerability of treatment | Up to 4 weeks | Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other symptoms of urogenital atrophy using the Urogenital Distress Inventory | Up to 4 weeks | 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. |
| Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare | Up to 4 weeks | 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. |
Countries
United States
Outcome results
None listed