Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Breast Carcinoma Clinical Trial

Official title:

Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

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
• 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
• 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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Cancer Survivor
• Carcinoma
• Cervical Carcinoma
• Dyspareunia
• Vaginal Dryness

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

External Links

•   The Jamesline