Clinical trial NCT03307044: Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Official title: Fractional CO2 Laser Therapy for Survivors of Breast Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Cancer Survivor
Cervical Carcinoma
Dyspareunia
Vaginal Dryness
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Vaginal Assessment Scale score
timeFrame: Baseline up to 4 weeks
measure: Patient compliance rates
timeFrame: Up to 4 weeks
measure: Feasibility of laser treatments defined by completion rates and tolerability of treatment
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Other symptoms of urogenital atrophy using the Urogenital Distress Inventory
timeFrame: Up to 4 weeks
measure: Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Allison Quick, MD
role: PRINCIPAL_INVESTIGATOR
References: