Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Body composition change - fat body mass (FBM)
研究概览
简要总结
This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT).
详细描述
Sarcopenia, decrease lean body mass (LBM) is the well-known parameter which negatively related to physical activity, morbidity and patients survival. Aging and decreased blood androgen level are well known risk factors of sarcopenia in male population.
Androgen deprivation therapy (ADT) is commonly performed in advanced or recurred prostate cancer patient and lead to accelerating decreasing blood androgen level. The previous studies defined the sarcopenia after ADT by calculated the (muscle component area) / (total body area) on computed tomography (CT) scan. However, CT scan is not recommended for routine follow up examination of ADT patients thus this measurement of sarcopenia has limitation on clinical usage.
This study using Inbody 320 for measure body composition. Inbody 320 based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Inbody measurement show precision accuracy and safety on body composition measurement, thus it frequently used in studies of obesity, nutrition and sports fields.
We calculating the total skeletal muscle mass (SMM), skeletal muscle index(SMI), relative skeletal muscle mass index (RASM), fat body mass (FBM), body mass index (BMI), body fat percentage, body water content, and edema value by Inbody 320 in the patients who treated by ADT in prostate cancer patients. Enrolled patients check the body composition parameters at the baseline (before ADT) and after ADT 3,6,12,18,24 months.
We prospectively measuring the 2 years changes of body composition and sarcopenia after ADT treatment. Patients characteristics (Age, underlying disease), Prostate cancer status (PSA level, Gleason grade group, initial treatment), ADT methods characters (timing, type) and oncological outcome (Recurrence, Metastasis, Castration resistance) were measuring in the cohort population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age over 20 year-old
- •Patient with ECOG-PS 0 to 2
- •Prostate cancer patients
- •Considered Androgen deprivation therapy with any cause
- •Patient agreed with informed consent of this study
排除标准
- •History of previous ADT
- •Planned intermittent treatment or short term ADT (less than 2 year)
- •Contraindication of ADT
- •Severe cognitive impairment, who cannot eligible for survey
- •Secondary malignancy
- •Patient cannot perform InBody test because of physical or underlying disease.
结局指标
主要结局
Body composition change - fat body mass (FBM)
时间窗: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
fat body mass (FBM) calculated by Inbody 320
Body composition change-Body mass index (BMI)
时间窗: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
{body weight (kg)} / {height (m)\^2}
Body composition change-Relative skeletal muscle index (RASM)
时间窗: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Sum of skeletal muscle mass in limbs (kg) / {height (m)\^2}
Body composition change-Skeletal muscle index (SMI)
时间窗: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Lean body mas (kg) / body weight (kg) x 100 (%)
次要结局
- Laboratory changes-PSA(Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months)
- Laboratory changes-Testosterone(Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months)
- Oncologic outcomes - recurrence(Up to 24 weeks)
- Oncologic outcomes - survival(Up to 24 weeks)