A Phase III, Double-Blind, Controlled Trial of Oxybutynin in the Management of Hot Flashes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
研究概览
简要总结
This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects.
ADAM-VTE
详细描述
PRIMARY OBJECTIVES:
I. To determine whether oxybutynin chloride (oxybutynin) can diminish hot-flash activity in women with a history of breast cancer or in women who have a concern about taking estrogen for fear of breast cancer.
SECONDARY OBJECTIVES:
I. To perform a dose-response evaluation of two oxybutynin doses. II. To determine the toxicity of oxybutynin in the study population. III. To assess the impact of hot-flash activity on overall quality of life and to examine whether oxybutynin can diminish this impact on quality of life.
OUTLINE: Patients are randomized into 1 of 4 groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS) (currently without evidence of malignant disease) OR a concern about taking estrogen for fear of breast cancer
- •Bothersome hot flashes (defined by their occurrence of >= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention)
- •Presence of hot flashes for > 30 days prior to study entry
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1
- •Ability to provide informed written consent
- •Life expectancy >= 6 months
- •Willing to work with the enrolling institution for follow-up (during the active monitoring phase of the study)
排除标准
- •Any of the following current (=< 4 weeks prior) or planned therapies:
- •Antineoplastic chemotherapy (anti-HER2 agents allowed)
- •Androgens
- •Estrogens (any delivery route)
- •Progestogens
- •Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period
- •Selective serotonin reuptake inhibitors (SSRIs)/serotonin?norepinephrine reuptake inhibitors (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration
- •Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration)
- •Clonidine
- •Agents with known potent anticholinergic activity; agents with mild-moderate anticholinergic activity are allowed
- •Prior use of oxybutynin during the period in which patient has had hot flashes
- •Pregnant women
- •Nursing women
- •History of any of the following contraindications to oxybutynin:
- •Uncontrolled gastroesophageal reflux disease (GERD) despite appropriate therapy; if patient has history of GERD, but symptoms are well-controlled with medical treatment, patient is eligible
- •Ulcerative colitis
- •Narrow-angle glaucoma
- •Urinary retention
- •Hypersensitivity to oxybutynin or any other components of the product
- •Current uncontrolled hyperthyroidism
- •Coronary heart disease (angina or prior myocardial infarction)
- •Congestive heart failure
- •Symptomatic cardiac arrhythmias
- •Current uncontrolled hypertension
- •Myasthenia gravis
研究组 & 干预措施
Group I (low-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Group I (low-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Oxybutynin Chloride (Drug)
Group I (low-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group II (low-dose placebo)
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Placebo (Other)
Group II (low-dose placebo)
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Group II (low-dose placebo)
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group III (high-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
干预措施: Oxybutynin Chloride (Drug)
Group III (high-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Group III (high-dose oxybutynin chloride)
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group IV (high-dose placebo)
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
干预措施: Placebo (Other)
Group IV (high-dose placebo)
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Group IV (high-dose placebo)
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
时间窗: Baseline up to day 49
Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity.
次要结局
- Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)(Up to 7 weeks)
- Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo(Baseline up to day 49)
- Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo(Baseline up to day 49)
- Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo(Baseline up to day 49)
- Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo(Baseline up to day 49)