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

The Ohio State University

Status: Completed

Conditions: Endometrial Carcinoma; Vulvar Carcinoma; Dyspareunia; Vaginal Dryness; Ovarian Carcinoma; Vaginal Carcinoma; Cervical Carcinoma

Treatments: Procedure: Laser Therapy; Procedure: Sham Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03372720

OSU-17261

NCI-2017-02051 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Arm I (fractional CO2 laser therapy)

Experimental group

Description:

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

Treatment:

Procedure: Laser Therapy

Other: Questionnaire Administration

Arm II (sham laser therapy)

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham Intervention

Other: Questionnaire Administration