Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

The Ohio State University

Status

Completed

Conditions

Dyspareunia

Vaginal Dryness

Cancer Survivor

Breast Carcinoma

Cervical Carcinoma

Treatments

Procedure: Laser Therapy

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

Identifiers

NCT03307044

NCI-2017-01554 (Registry Identifier)

OSU-17153

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Volunteers

No Healthy Volunteers

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