A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient initiation rate
研究概览
简要总结
The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.
详细描述
Prostate cancer (PCa) is among the most frequent tumor types and is the second deadliest type of cancer in men.
PCa has a multifactorial aetiology; modifiable environmental factors, including diet and obesity, have been associated with prostate carcinogenesis. Furthermore, patients with PCa are treated with androgen deprivation therapy (ADT), which has negative effects on the cardiovascular system and body composition, particularly on the fat and muscle mass, bone health and psychological wellbeing.
Data in the current literature suggests that a lifestyle intervention e.g. with targeted and supervised exercise therapy or a dietary intervention with a prudent dietary patternmay positively influence the quality of life and the course of the disease of patients under ADT. However, conclusive data is missing.
The proposed pilot study aims at determining the feasibility and the effect of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with PCa under ADT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to ICH/GCP regulations before registration.
- •Age ≥ 18 years
- •Histology of adenocarcinoma of the prostate
- •Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)
- •Rising PSA (two consecutively rising PSA levels > 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation
- •PSA doubling time > 8 weeks
- •Continuation of ongoing systemic treatment is deemed feasible by treating physician
排除标准
- •Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments
- •Evidence of clinical progression or progression of disease on imaging
- •Bone metastases excluding the safety of physical exercise
- •Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures
- •Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening)
- •Clinically significant chronic obstructive pulmonary disease
- •Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study
结局指标
主要结局
Patient initiation rate
时间窗: 12 weeks
Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
Adherence to prescribed training program
时间窗: 12 weeks
Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
Patient retention rate
时间窗: 12 weeks
Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
Adherence to prescribed dietary regimen
时间窗: 12 weeks
Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
次要结局
- Effect of lifestyle intervention on PSA progression(24 weeks)
- Effect of lifestyle intervention on PSA levels(24 weeks)
- Effect of lifestyle intervention on time to subsequent treatment(24 months)
- Effect of lifestyle intervention on plasma immune signature(8 weeks)
- Effect of lifestyle intervention on patient-reported quality of life(24 weeks)
- Effect of lifestyle intervention on patient-reported fatigue(24 weeks)
- Effect of lifestyle intervention on radiographic progression(24 weeks)
- Effect of lifestyle intervention on plasma lipid signature(8 weeks)
- Effect of lifestyle intervention on microbiome composition(8 weeks)
- Effect of lifestyle intervention on anthropometric variables(24 weeks)
- Effect of lifestyle intervention on lean body mass(12 weeks)
- Effect of lifestyle intervention on fat body mass(12 weeks)