Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Primary Purpose
Breast Carcinoma, Cancer Survivor, Cervical Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Therapy
Questionnaire Administration
Sponsored by
About this trial
This is an interventional treatment trial for Breast Carcinoma
Eligibility Criteria
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (fractional CO2 laser therapy)
Arm Description
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
Outcomes
Primary Outcome Measures
Change in Vaginal Assessment Scale score
Using Vaginal Assessment Scale (VAS)
Patient compliance rates
Compliance rates with treatment will be assessed.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03307044
First Posted
August 31, 2017
Last Updated
March 17, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03307044
Brief Title
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Official Title
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
May 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Cancer Survivor, Cervical Carcinoma, Dyspareunia, Vaginal Dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (fractional CO2 laser therapy)
Arm Type
Experimental
Arm Description
Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
Intervention Type
Procedure
Intervention Name(s)
Laser Therapy
Other Intervention Name(s)
Therapy, Laser
Intervention Description
Undergo fractional CO2 laser therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Vaginal Assessment Scale score
Description
Using Vaginal Assessment Scale (VAS)
Time Frame
Baseline up to 4 weeks
Title
Patient compliance rates
Description
Compliance rates with treatment will be assessed.
Time Frame
Up to 4 weeks
Title
Feasibility of laser treatments defined by completion rates and tolerability of treatment
Description
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 Outcome Measure Information:
Title
Other symptoms of urogenital atrophy using the Urogenital Distress Inventory
Description
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
Title
Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare
Description
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Quick, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
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