EXALT: EXercise Attenuates Liver Tumors Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Acceptability-scientifically adequate
研究概览
简要总结
The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.
详细描述
Primary liver cancer is the leading cause of cancer worldwide. The majority of primary liver cancers are hepatocellular carcinoma (HCC) and occur in the setting of cirrhosis of the liver. Body fat and systemic inflammation are determinants of HCC risk. Cirrhotic patients with HCC are often treated with locoregional therapies including transarterial chemoembolization (TACE) as a bridge to liver transplantation. Despite this, HCC recurrence rates approach 80%. There is a growing body of evidence to suggest the benefit of exercise in cancer patients. Exercise decreases disease recurrence and improves survival in other primary cancers by altering tumor biology and influencing response to treatment. Although animal models suggest biologic plausibility, whether or not exercise prevents HCC recurrence in cancer patients remains unknown. The overall goal of this proposal is to test the effect of exercise to delay or avert HCC recurrence and gain information regarding the potential molecular mechanisms of HCC tumor inhibition by exercise.
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age >=18 or <70 years
- •Liver transplant candidates (under evaluation or listed for transplant with HCC)
- •Hepatocellular Carcinoma diagnosis (HCC)
- •Complete response to LRT
排除标准
- •Active cardiac symptoms
- •BMI <18 or >45 kg/m2(16)
- •CPT Class B or C liver disease
- •Hepatic decompensation
- •Institutionalized/prisoner
- •Pregnancy
- •Severe medical comorbidities/psychiatric illness
结局指标
主要结局
Acceptability-scientifically adequate
时间窗: up to 52 weeks
To assess the effectiveness of exercise trials in patients with HCC. The work with the ongoing NASHFit and completed ENACT Trials and the work of others performing exercise-based trials in patients with cirrhosis(50) has established \>50% enrollment of subjects approached as a threshold of acceptability.
Feasibility-number of participants able to complete the trial
时间窗: up to 52 weeks
Defined as completing \>80% of the sessions.(46, 47) While this would be expected for patients with cirrhosis,(46) this would be five-fold larger than the proportion of oncology patients receiving systemic treatment who complete other exercise based randomized controlled trials. We expect exercise in subjects with HCC in the background of Child Pugh Turcotte (CPT) Class A cirrhosis without hepatic decompensation (e.g., ascites, hepatic encephalopathy, bleeding gastroesophageal varices) and Eastern Cooperative Oncology Group (ECOG) 0-2 functional status to be feasible.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: up to 52 weeks
Data from previous oncology trials suggest up to 25% of the participants may experience a mild musculoskeletal impairment and zero adverse effects requiring treatment alterations. Pilot exercise-based trials in patients with cirrhosis have demonstrated \<5% adverse events.
次要结局
- HCC recurrence(3- and 6- month)
- visceral adipose tissue (VAT)(3- and 6-month)
- concentration of IL-6(3- and 6-month)
- Overall survival(3- and 6- month)
- waiting-list mortality(3- and 6- month)
- Cancer-free survival(3- and 6- month)
研究者
Jonathan Stine
Assistant Professor Medicine
Milton S. Hershey Medical Center