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临床试验/NCT03157323
NCT03157323进行中(未招募)不适用

Implementing a Low Glycemic Diet in Children and Adolescents Undergoing Treatment for Acute Lymphoblastic Leukemia

Columbia University9 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
88
试验地点
9
主要终点
Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL.

研究概览

简要总结

The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

详细描述

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy with survival exceeding 90%. However, treatment-related toxicity remains a clinical challenge during and after treatment. Evidence-based, nutritional interventions may minimize the development of nutrition-related toxicities, such as bone morbidities, hypertriglyceridemia, and obesity. To date, no effective interventions are available to prevent nutrition-related morbidities in children with ALL. Clinical studies evaluating the glycemic indices in other pediatric conditions have been encouraging. It is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population. Prior to the design and implementation of randomized, controlled trials, epidemiological data describing the Glycemic Index (GI) and Glycemic Load (GL) and the association with clinically important outcomes is needed. Additionally, the feasibility of a dietary intervention must also be explored within the setting of pediatric cancer. This study aims to determine the feasibility, measured by compliance to a low-GI diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. The proposed work will be used for the design and implementation of a multi-center nutritional intervention aimed at improving dietary intake during treatment and its effect on clinically important outcomes. Importantly, the information will be used to drive the formation of evidence-based nutritional guidelines for children with cancer, which will expand into the emerging field of individualized medicine for patients with cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Acute Lymphoblastic Leukemia (B-Cell, T-Cell, or Mixed Phenotype)
  • Within 3 days of starting the induction phase of treatment for Acute Lymphoblastic Leukemia
  • Proficient in English or Spanish

排除标准

  • Diagnosis of relapsed Acute Lymphoblastic Leukemia
  • Not meeting all of the inclusion criteria

研究组 & 干预措施

Low Glycemic Index Diet

Other

Following a low glycemic index diet verses a standard american diet.

干预措施: Low Glycemic Index Diet (Behavioral)

结局指标

主要结局

Feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL.

时间窗: 6 months

Feasibility will be measured by compliance to a low glycemic index diet, which will be measured via 24 dietary recall, using the Automated Self-Administered 24-Hour Dietary Assessment Tool. A dietary recall will be taken at 7 timepoints from diagnosis to end of treatment; each recall will be defined categorically as high compliance (GI score \<55), moderate compliance (GI score 56-69) and low compliance (GI score \>70). Change in glycemic index score will show compliance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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