Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
研究概览
简要总结
Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •patient over 18 y.o
- •Breslow index > 1mm or any Breslow index with ulcerated primary lesion
- •Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc
- •Able to undergo outpatient treatment
排除标准
- •No contra indication for betablockers as defined by the compendium
- •No clinical evidence of coagulopathy
- •No unstable angina pectoris
- •No AV-block II or III without pacemaker
- •No severe congestive heart failure
- •No untreated phaeochromocytoma
- •No severe bradycardia
- •No severe hypotension
- •No severe impairment of peripheral arterial circulation
- •No uncontrolled cardiac arrhythmia
- •No severe asthma or COPD
- •No uncontrolled diabetes mellitus
- •No Angioneurotic edema
- •No severe Aortic valve stenosis
- •No severe hypertrophic cardiomyopathy
- •No severe renal dysfunction
- •No patients on beta blockers by inclusion
- •No known adverse reaction to betablockers
- •No pregnant or lactating patients can be included
- •No melanoma stage AJCC IV by inclusion
- •No patients requiring a specific oncological treatment
研究组 & 干预措施
Placebo
113 patients will be enrolled in the placebo group with respect to randomization.
Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group.
The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness.
干预措施: Placebo pill (Drug)
Betablocker
drug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol.
The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day.
One long acting pill a day until an evidence of disease progression or the end of the study.
干预措施: Propranolol hydrochloride (Drug)
结局指标
主要结局
Efficacy of propranolol on progression free survival for patients suffering from a primary melanoma with a high risk of recurrence
时间窗: five years
The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease. We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.
次要结局
- Use of serum microRNA profile as a predictor for recurrence(5 years)
- Overall survival(5 years)
研究者
Le Gal
Associate Physician, PD, MD/PhD
University Hospital, Geneva