A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Efficacy: hot flash composite and frequency scores (daily diary)
研究概览
简要总结
Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).
详细描述
There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Women with a history of invasive breast cancer or DCIS
- •Currently taking aromatase inhibitors or tamoxifen
- •Not receiving hormone replacement therapy for minimum of one month
- •Age 18 years or older
- •Self-reported hot flashes at least fourteen times per week
- •Self-reported hot flashes for at least one month
- •If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.
排除标准
- •Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
- •Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
- •History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
- •Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
- •Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
- •Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
- •Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history & physical exam and medical record)
- •Hypotension or uncontrolled hypertension (160/95 > BP < 100/60)
- •Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history & physical and medical record)
- •History of allergy or adverse reactions to clonidine or solifenacin
- •ECOG status > 2 (in bed more than 50% of day)
研究组 & 干预措施
solifenacin
oral solifenacin 5.0 mg daily for 3 weeks
干预措施: solifenacin (Drug)
clonidine
oral clonidine 0.1 mg daily for 3 weeks
干预措施: Clonidine (Drug)
结局指标
主要结局
Efficacy: hot flash composite and frequency scores (daily diary)
时间窗: from baseline to end of treatment (3 weeks)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Safety: number of clinician-rated adverse events
时间窗: from consent until end of study (approximately 9 weeks)
to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
次要结局
- sleep (Insomnia Severity Index)(from baseline to end of treatment (3 weeks))
- daily functioning (Hot Flash-Related Daily Interference score)(from baseline to end of treatment (3 weeks))
- quality of life (Illness Cognition Questionnaire, SF-12)(from baseline to end of treatment (3 weeks))