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

Ovarian Carcinoma Clinical Trial

Official title:

Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372720
• Other study ID #: OSU-17261
• Secondary ID: NCI-2017-02051
• Status: Completed
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 12, 2022
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma
• Dyspareunia
• Endometrial Carcinoma
• Endometrial Neoplasms
• Ovarian Carcinoma
• Vaginal Carcinoma
• Vaginal Dryness
• Vaginal Neoplasms
• Vulvar Carcinoma
• Vulvar Neoplasms

Intervention

Procedure:
• Laser Therapy
Undergo fractional CO2 laser therapy

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Sham Intervention
Undergo sham laser therapy

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Improvement in sexual function by FSFI	Will determine improvement in sexual function as measured by Female Sexual Function Index (FSFI)	Up to 1 year
Secondary	Improvement in sexual function FSDS	Will determine improvement in sexual function as measured by Female Sexual Distress Scale-Revised (FSDS)	Up to 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The Jamesline