Clinical trial NCT03372720: Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Official title: Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Dyspareunia
Endometrial Carcinoma
Ovarian Carcinoma
Vaginal Carcinoma
Vaginal Dryness
Vulvar Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 19
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in genitourinary syndrome of menopause (GSM) symptoms
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Feasibility as measured by number of patients able to complete 3 study visitis
timeFrame: Up to 1 month
measure: Improvement in objective findings of vaginal atrophy
timeFrame: Up to 1 month
measure: Improvement in sexual function by FSFI
timeFrame: Up to 1 year
measure: Improvement in sexual function FSDS
timeFrame: Up to 1 year
measure: Improvement in urinary symptoms
timeFrame: Up to 1 month
measure: Incidence of adverse events
timeFrame: Up to 1 month
measure: Number of patients complete all treatments
timeFrame: Up to 1 month
measure: Satisfaction with vaginal fractional CO2 laser therapy
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
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:
citation: Quick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas. 2021 Feb;144:37-44. doi: 10.1016/j.maturitas.2020.10.018. Epub 2020 Dec 2.