Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

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.

• Laser Therapy (Procedure), also known as Therapy, Laser: Undergo fractional CO2 laser therapy
• Questionnaire Administration (Other): Ancillary studies

Primary outcomes

• Change in Vaginal Assessment Scale score [Baseline up to 4 weeks]: Using Vaginal Assessment Scale (VAS)
• Patient compliance rates [Up to 4 weeks]: Compliance rates with treatment will be assessed.
• 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 outcomes

• 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.

Sex: Female

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

• Allison Quick, MD, Principal investigator, Ohio State University Comprehensive Cancer Center