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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Carcinoma; Endometrial Carcinoma; Vaginal Carcinoma; Ovarian Carcinoma; Vulvar Carcinoma; Vaginal Dryness; Dyspareunia
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Laser Therapy; Procedure: Sham Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (fractional CO2 laser therapy); Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.	Other: Questionnaire Administration; Ancillary studies; Procedure: Laser Therapy; Undergo fractional CO2 laser therapy; Other Names: Therapy, Laser
Sham Comparator: Arm II (sham laser therapy); Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.	Other: Questionnaire Administration; Ancillary studies; Procedure: Sham Intervention; Undergo sham laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in genitourinary syndrome of menopause (GSM) symptoms	Will be assessed by the Vaginal Assessment Scale (VAS). Will be summarized and compared between the treatment arms using a two-sample t-test or a Wilcoxon rank sum test, with a two-sided alternative for each. Will also analyze this endpoint graphically by plotting the VAS scores through time by treatment arm. Additionally, will correlate the scores from the VAS with other validated measures using a Spearman's correlation coefficient in an exploratory manner.	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by number of patients able to complete 3 study visitis	A crossover design to determine the feasibility of the crossover design for potential use in a phase III trial by summarizing the proportion of patients who are unable to tolerate the study treatment prior to completing the 3 treatments	Up to 1 month
Improvement in objective findings of vaginal atrophy	Will determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.	Up to 1 month
Improvement in sexual function by FSFI	Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI)	Up to 1 year
Improvement in sexual function FSDS	Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS)	Up to 1 year
Improvement in urinary symptoms	Will determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI). The change in dyspareunia and dryness between baseline (T0) and T4 will be calculated and compared between the treatment and sham arms using a two sample t-test or Wilcoxon rank sum test.	Up to 1 month
Incidence of adverse events	Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)	Up to 1 month
Number of patients complete all treatments	Summarize the proportion of patients who are able to tolerate the study treatment and complete the 3 treatments.	Up to 1 month
Satisfaction with vaginal fractional CO2 laser therapy	Patients will be asked to rate their satisfaction with the procedure on a likert-type scale of 1-10 with 1 being completely dissatisfied and 10 being extremely satisfied. Participants will be asked to rate their satisfaction on this scale after each treatment and at follow-up.	Up to 1 month

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): April 12, 2022

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vaginal Diseases; Vulvar Diseases; Carcinoma; Endometrial Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Dyspareunia
• Other Study ID Numbers: OSU-17261; NCI-2017-02051 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No