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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2022-04-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (fractional CO2 laser therapy)

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

Group Type EXPERIMENTAL

Laser Therapy

Intervention Type PROCEDURE

Undergo fractional CO2 laser therapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (sham laser therapy)

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

Group Type SHAM_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Sham Intervention

Intervention Type PROCEDURE

Undergo sham laser therapy

Interventions

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Laser Therapy

Undergo fractional CO2 laser therapy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Sham Intervention

Undergo sham laser therapy

Intervention Type PROCEDURE

Other Intervention Names

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Therapy, Laser

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No