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临床试验/NCT03256201
NCT03256201进行中(未招募)不适用

Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
95
试验地点
2
主要终点
Retention

研究概览

简要总结

This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

详细描述

This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.

In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.

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
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Retention

时间窗: 2 year

Retention as the percentage of enrolled patients retained assessment point

Accrual

时间窗: 2 year

The percentage of eligible patients enrolled

Adherence

时间窗: 2 year

Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls

次要结局

  • Physical Performance(Approximately 4 months post-op)
  • Quality of Life Assessment(Approximately 1-3 days pre-op)
  • Assessment of Symptoms(Approximately 1-3 days pre-op)
  • Change in Body Weight(Approximately 1-3 days pre-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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