Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Cancer Survivor; Cervical Carcinoma; Vaginal Dryness; Dyspareunia
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Laser Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (fractional CO2 laser therapy); Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.	Other: Questionnaire Administration; Ancillary studies; Procedure: Laser Therapy; Undergo fractional CO2 laser therapy; Other Names: Therapy, Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vaginal Assessment Scale score	Using Vaginal Assessment Scale (VAS)	Baseline up to 4 weeks
Patient compliance rates	Compliance rates with treatment will be assessed.	Up to 4 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Breast Neoplasms; Carcinoma; Dyspareunia
• Other Study ID Numbers: OSU-17153; NCI-2017-01554 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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