Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Change in genitourinary syndrome of menopause (GSM) symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (fractional CO2 laser therapy)
Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
干预措施: Laser Therapy (Procedure)
Arm I (fractional CO2 laser therapy)
Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
干预措施: Questionnaire Administration (Other)
Arm II (sham laser therapy)
Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
干预措施: Questionnaire Administration (Other)
Arm II (sham laser therapy)
Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
干预措施: Sham Intervention (Procedure)
结局指标
主要结局
Change in genitourinary syndrome of menopause (GSM) symptoms
时间窗: 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.
次要结局
- Improvement in objective findings of vaginal atrophy(Up to 1 month)
- Feasibility as measured by number of patients able to complete 3 study visitis(Up to 1 month)
- Improvement in urinary symptoms(Up to 1 month)
- Satisfaction with vaginal fractional CO2 laser therapy(Up to 1 month)
- Incidence of adverse events(Up to 1 month)
- Number of patients complete all treatments(Up to 1 month)
- Improvement in sexual function by FSFI(Up to 1 year)
- Improvement in sexual function FSDS(Up to 1 year)
研究者
Allison Quick
Principal Investigator
Ohio State University Comprehensive Cancer Center