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

Not Applicable

Completed

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

• Registration Number: NCT03372720
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Study Start: 2018-05-11
• Primary Completion: 2019-12-18
• Status Verified: 2022-04
• Study Completion: 2022-04-12
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (fractional CO2 laser therapy)	Laser Therapy	Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
Arm I (fractional CO2 laser therapy)	Questionnaire Administration	Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
Arm II (sham laser therapy)	Questionnaire Administration	Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
Arm II (sham laser therapy)	Sham Intervention	Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.

Primary Outcome Measures

Name	Time	Method
Change in genitourinary syndrome of menopause (GSM) symptoms	Baseline to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in objective findings of vaginal atrophy	Up to 1 month	Will determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
Feasibility as measured by number of patients able to complete 3 study visitis	Up to 1 month	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
Improvement in urinary symptoms	Up to 1 month	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.
Satisfaction with vaginal fractional CO2 laser therapy	Up to 1 month	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.
Incidence of adverse events	Up to 1 month	Adverse event grading will be done according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE)
Number of patients complete all treatments	Up to 1 month	Summarize the proportion of patients who are able to tolerate the study treatment and complete the 3 treatments.
Improvement in sexual function by FSFI	Up to 1 year	Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI)
Improvement in sexual function FSDS	Up to 1 year	Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS)

Trial Locations

Locations (4)

Sanford Roger Maris Cancer Center; 🇺🇸 Fargo, North Dakota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States