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临床试验/NCT04024618
NCT04024618Unknown不适用

A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Enrollment of patients

研究概览

简要总结

This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.

详细描述

This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient.

Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is < 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is >80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to <80% of required nutritional intake.

Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients aged 18 to 75 years.
  • Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit.
  • Patient consented to participate in the study
  • Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma
  • Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan
  • Have a functional Gastrointestinal tract

排除标准

  • Intestinal obstruction
  • Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction.
  • Patients with active bacteremia while proceeding with transplant
  • Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (< 4 weeks)
  • Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized

结局指标

主要结局

Enrollment of patients

时间窗: 30 days

The number of patients enrolled

次要结局

  • Duration of Support(21 days)
  • Changes in costs(21 days)
  • Changes in Lean Muscle(21 Days)
  • quadriceps muscle layer thickness(21 days)
  • Hospital Stay(21 days)
  • Mortality(30 days)
  • Changes in body fat(21 Days)
  • Changes in costs to hospital when using enteral nutritional(21 Days)
  • Transition from EN to oral feeding(15 Days)

研究者

研究点 (2)

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