2023-504704-28-00
招募中
2 期
Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)
Central Finland Hospital District Central Finland Hospital Nova4 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2023年8月21日最近更新:
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Central Finland Hospital District Central Finland Hospital Nova
- 入组人数
- 310
- 试验地点
- 4
- 主要终点
- Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
概览
简要总结
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with localized PCa starting radiotherapy with adjuvant ADT at least for one year
- •Adults (age over 18 years)
- •Sufficient performance status ECOG 0-1
- •Willingness to participate and signed consent
- •Body mass index between 18.5 – 30.0
排除标准
- •Patients with low-risk PCa
- •Physical disabilities for regular exercise
- •Any medication or condition considered as a contraindication to estradiol (allergy to adjuvant compounds (carbomer, trolamine), history with thromboembolic disorders (protein C, protein S, or antithrombin deficiency), porphyria, acute or previous liver disease, drugs with cytochrome P450 enzyme metabolism (anticonvulsants: phenobarbital, phenytoin, carbamazepine; anti-infectives: rifampicin, rifapentine, nevirapine, efavirenz; and St. John's wort)) or leuprorelin (allergy to adjuvant compounds (polylactic acid), Qt-time prolonging drugs (quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone, moxifloxacin, antipsychotics)
- •Known allergy to estradiol or leuprorelin
- •Expected poor compliance or expected survival time of less than one year
- •Patients with expected adjuvant ADT for less than one year
- •Distant bone, lymph node, or soft tissue metastasis
- •Cardiac pacemaker
- •Diabetes Mellitus
- •Prior cardiovascular event or stroke (<12 months)
结局指标
主要结局
Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
次要结局
- Occurrence of ADT-induced adverse effects during ADT in different study groups
- Tolerability and safety of transdermal E2 during the one-year ADT adjuvant treatment period
- Impact of transdermal E2 with or without 6-month resistance exercise on the muscle strength, functional capacity, body composition, lean-body muscle mass, and systematic biomarkers (g.e., blood biomarkers of and inflammatory health and muscle biomarkers)
- Safety and tolerability of 6-month physical exercise combined with or without transdermal E2 during ADT
- Quality of life and perceived fatigue during ADT in different study groups
研究者
Heikki Seikkula
Scientific
Central Finland Hospital District Central Finland Hospital Nova
研究点 (4)
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