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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03307044
Other study ID # OSU-17153
Secondary ID NCI-2017-01554
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2017
Est. completion date May 5, 2022

Study information

Verified date March 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Laser Therapy
Undergo fractional CO2 laser therapy
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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