Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Composition (Lean Body Mass)
研究概览
简要总结
This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.
详细描述
It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Age 60 years or older
- •Patients with asymptomatic or minimally symptomatic prostate cancer for which they are about to start androgen deprivation therapy (ADT) per provider recommendation
- •Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed
- •Men receiving ADT for localized prostate cancer are allowed
- •Patient able to give informed consent.
排除标准
- •Patient already on ADT
- •Patients who are visiting clinic for a second opinion only
- •Patients with a diagnosis of dementia
- •Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
研究组 & 干预措施
Standard of care ADT + (HMB + AG)
Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)
干预措施: Standard of care ADT + (HMB + arginine + glutamine) (Drug)
Standard of care ADT
Standard of care androgen deprivation therapy
干预措施: Standard of care ADT (Other)
结局指标
主要结局
Change From Baseline in Body Composition (Lean Body Mass)
时间窗: Baseline, 3 months
This measure will be the change of lean body mass from baseline reported in kilograms.
次要结局
- Change From Baseline of Dorsiflexor Muscle Size in mm^2.(Baseline and 3 months)
- Physical Performance Measured Using the Short Physical Performance Battery (SPPB)(Baseline and 3 months)
- Change From Baseline in the Number of Fall Events(Baseline, 3 months)
- Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.(Baseline and 3 months)
研究者
Kathryn A Bylow, MD
Associate Professor of Medicine
Medical College of Wisconsin