Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors



Status:Recruiting
Conditions:Ovarian Cancer, Cervical Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:8/30/2018
Start Date:March 28, 2018
End Date:December 31, 2020
Contact:The Ohio State University Comprehensive Cancer Center
Email:OSUCCCClinicaltrials@osumc.edu
Phone:800-293-5066

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Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies

This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy
works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer
survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of
gynecologic cancers.

PRIMARY OBJECTIVES:

I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with
vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal
laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).

SECONDARY OBJECTIVES:

I. To evaluate toxicity associated with vaginal laser therapy in this population.

II. To determine how many women with the defined patient eligibility will complete all
treatments.

III. To determine the feasibility of the crossover design for potential use in a phase III
trial.

IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser
therapy versus sham treatment.

V. To determine improvement in sexual function as measured by Female Sexual Function Index
(FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and
behavior with vaginal laser therapy versus sham treatment.

VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser
therapy versus sham treatment using the Urogenital Distress Inventory (UDI).

VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.

OUTLINE: Patients are randomized in to 1 of 2 arms.

ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.

ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then
crossover to Arm I.

After completion of study, patients are followed up at 1 month.

Inclusion Criteria:

- Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed
all cancer related treatment >= 6 months prior to enrollment

- Any form of hysterectomy, including radical hysterectomy permitted

- Must have no evidence of recurrent disease on pelvic exam within past 3 months

- Radiation therapy is permitted but not required

- Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale
from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the
inability to be sexually active due to pain

Exclusion Criteria:

- Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or
ovarian cancer

- Pelvic organ prolapse stage II or higher

- Prior reconstructive pelvic surgery involving mesh

- Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to
enrollment
We found this trial at
4
sites
Rochester, Minnesota 55905
Principal Investigator: Stephanie S. Faubion, MD
Phone: 507-293-1487
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Jenelle Coleman, MD
Phone: 410-955-0646
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Columbus, Ohio 43210
Principal Investigator: Maryam Lustberg, MD
Phone: 614-293-8858
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Fargo, North Dakota 58122
Principal Investigator: Shelby Terstriep, MD
Phone: 605-312-3264
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Fargo, ND
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