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临床试验/NCT02990130
NCT02990130进行中(未招募)不适用

Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

Garcia, Jose M., MD, PhD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
6-Minute Walk Test change

研究概览

简要总结

This proposal aims to characterize biochemical and physiologic factors that contribute to changes in patient fitness and body composition during hematopoietic stem cell transplantation (HCT) for hematologic malignancies. The study group will consist of 60 patients with hematologic malignancies treated with HCT. Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT.

详细描述

This proposal aims to characterize biochemical and physiologic factors that contribute to changes in patient fitness and body composition during hematopoietic stem cell transplantation (HCT) for hematologic malignancies. The investigators hypothesize that: 1) HCT for hematologic malignancies is associated with a change in biochemical and physiologic factors that reflect patient fitness and 2) Baseline (pre-HCT) and post-HCT changes of biochemical and physiologic factors that reflect patient fitness are associated with HCT-related clinical outcomes.This is a pilot study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. No vulnerable population will be included. The study group will consist of 60 patients with hematologic malignancies treated with HCT.

Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT. Data collection may include:

  1. Blood tests other than those performed as clinical standard of care may include: anabolic and catabolic factors such as IGF-1, GH, IGFBP-3, free and weakly bound testosterone, IL-6, CRP, TNF-alpha, and pre-albumin.
  2. Measurements of fitness other than those obtained as clinical standard of care may include: resting energy expenditure (REE) assessed by indirect calorimetry; body composition measured by bio-impedance (BIA) and dual-energy x-ray absorptiometry (DEXA) scan; handgrip strength; stair climbing power; 6-minute walk test; muscle strength; maximal oxygen consumption (VO2 max); and previously validated questionnaires to assess patient quality of life (QOL) and functional status.
  3. Additional data that may be collected for this protocol will include clinical and laboratory data acquired per standard of clinical care as pertains to subjects' co-morbidities, hematologic disease and treatment history, and clinical course including nutritional status, use of nutrition support, and estimated nutritional requirements per routine dietitian assessments. A Food Frequency Questionnaire will be administered by a dietitian in addition to the routine clinical assessments.

The primary endpoint of this study is the change over time of patient fitness as assessed by the 6 minute walk test through HCT. Secondary endpoints will include other markers of anabolism and catabolism, and data collected as mentioned above.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed hematologic malignancy.
  • Undergoing evaluation at the BMTU at the Puget Sound VA.
  • Planning or receiving an autologous or allogeneic HCT

排除标准

  • Patients who for any reason elect not to participate.

结局指标

主要结局

6-Minute Walk Test change

时间窗: from baseline to 30 days (+/- 10 days) after HCT

maximum distance walked in 6 minutes

次要结局

  • physical function changes(from baseline to 30 days (+/- 10 days) after HCT)
  • body composition changes(from baseline to 30 days (+/- 10 days) after HCT)
  • Muscle strength(from baseline to 30 days (+/- 10 days) after HCT)
  • maximal oxygen consumption changes(from baseline to 30 days (+/- 10 days) after HCT)
  • nutritional status(from baseline to 30 days (+/- 10 days) after HCT)
  • Anabolic marker changes(from baseline to 30 days (+/- 10 days) after HCT)
  • Inflammatory marker changes(from baseline to 30 days (+/- 10 days) after HCT)
  • resting energy expenditure changes(from baseline to 30 days (+/- 10 days) after HCT)
  • Quality of Life change score(from baseline to 30 days (+/- 10 days) after HCT)
  • Food Frequency Questionnaire(from baseline to 30 days (+/- 10 days) after HCT)
  • use of nutrition support(from baseline to 30 days (+/- 10 days) after HCT)
  • estimated nutritional requirements(from baseline to 30 days (+/- 10 days) after HCT)

研究者

发起方
Garcia, Jose M., MD, PhD
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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