NCT03666819撤回2 期
Phase II Trial of CO2RE Laser for Patients With Stage 0-III Hormone Receptor-Positive Breast Cancer on Aromatase Inhibitors With Vulvovaginal Atrophy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
研究概览
简要总结
This phase II trial studies how well carbon dioxide fractional (CO2RE) laser works in treating participants with stage 0-III hormone receptor-positive breast cancer with vulvovaginal atrophy associated with dryness, inflammation or thinning of the epithelial lining of the vulva and vagina. CO2RE laser is a device that delivers controlled CO2 energy to the vaginal tissue and may help treat vaginal symptoms such as itching, burning, painful sexual intercourse, thickened or thin skin of the vulva, and stinging.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the reduction in Vulvovaginal Symptom Questionnaire (VSQ) score at 3-month follow up after CO2RE laser treatment.
SECONDARY OBJECTIVES:
I. To evaluate the reduction in VSQ score after CO2RE laser treatment 6-month follow-up and 12-month follow-up.
II. To evaluate Female Sexual Function Index (FSFI) score before and after treatment with CO2RE laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of adenocarcinoma of the breast stage 0-III
- •Evidence of hormone sensitivity with estrogen receptor (ER) and/or progesterone receptor (PR) positive >= 1% of primary tumor tissue
- •Currently or will be starting on aromatase inhibitor (letrozole, anastrozole, or exemestane)
- •Willingness to self-report vaginal itching, dryness, or dyspareunia
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Obtained =< 28 days prior to registration: Hemoglobin >= 8.0 g/dL
- •Obtained =< 28 days prior to registration: Absolute neutrophil count (ANC) >= 1500/mm^3
- •Obtained =< 28 days prior to registration: Platelet count >= 75,000/mm^3
- •Obtained =< 28 days prior to registration: Total bilirubin =< 3.0 x upper limit of normal (ULN)
- •Obtained =< 28 days prior to registration: Aspartate transaminase (AST) =< 3 x ULN
- •Obtained =< 28 days prior to registration: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 2 x ULN OR if patient is receiving anticoagulant therapy and PT/INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of coagulants
- •Obtained =< 28 days prior to registration: Calculated creatinine clearance =< 3 x ULN
- •Recent negative Papanicolaou (PAP) smear within 1 year. In patients who do not have recent PAP smear, PAP smear should be obtained as per standard of care during the screening process prior to enrollment
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide written informed consent
- •Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
排除标准
- •Previous use of CO2 fractional within 1 year
- •Receiving any form of hormone replacement therapy, including topical estrogens, testosterone, and dehydroepiandrosterone (DHEA) or selective estrogen receptor modulator (SERM), including tamoxifen and ospemifene
- •History of or current dysplastic nevi in the area that will be treated
- •Prolapse uterus > stage II according to the International Continence Society pelvic organ prolapse quantification (ICS-POP-Q) system
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the treatment
- •Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Evidence of urinary tract infection (UTI) based on the urinalysis (UA) at the time of the screening. Patients with evidence of UTI can be enrolled after UTI is treated and repeated UA and/or urine culture shows no further evidence of ongoing infection
- •Evidence of injuries, bleeding, or evidence suggestive of dysplasia in the external vaginal area or vaginal canal
结局指标
主要结局
Reduction in Vulvovaginal Symptom Questionnaire (VSQ) (symptoms, emotions, and life-impact)
时间窗: Baseline up to 3 months
Descriptive statistics (mean, standard deviation \[SD\], median, interquartile range \[IQR\]) using frequency table and histogram will be used to summarize the reduction in the sum of VSQ total score first three scales of the VSQ (symptoms, emotions, and life-impact) at 3 months after treatment versus (vs.) baseline.
次要结局
- Discomfort and pain during carbon dioxide fractional (CO2RE) laser treatment using the visual analog scale(Up to 12 months)
- Female Sexual Function Index (FSFI) score(Baseline up to 12 months)
- Vaginal caliber(Baseline up to 12 months)
- Treatment satisfaction as measured by 5-point Likert scale(Up to 12 months)
- Adherence to aromatase inhibitor as measured by the Simplified Medication Adherence Questionnaire(Up to 12 months)
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(Up to 12 months)
- Urogenital Distress Inventory (UDI) 6 score(Baseline up to 12 months)
- Vaginal health index score(Baseline up to 12 months)
- Reduction in VSQ score (symptoms, emotions, and life-impact)(Baseline up to 12 months)
研究者
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