Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Not Applicable

Completed

• Conditions: Cervical Carcinoma; Breast Carcinoma; Dyspareunia; Cancer Survivor; Vaginal Dryness
• Interventions: Procedure: Laser Therapy; Other: Questionnaire Administration

• Registration Number: NCT03307044
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-11
• Study Start: 2017-11-16
• Primary Completion: 2018-12-21
• Study Completion: 2022-05-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (fractional CO2 laser therapy)	Laser Therapy	Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
Treatment (fractional CO2 laser therapy)	Questionnaire Administration	Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.

Primary Outcome Measures

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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States