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临床试验/NCT00726934
NCT00726934已完成不适用

The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Indiana University6 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2007年9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
已完成
入组人数
149
试验地点
6
主要终点
Neutropenic Infection

研究概览

简要总结

The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of pediatric cancer patients.

详细描述

Historically, many interventions have been tried to reduce the incidence of infection by reducing patients' exposures to potential pathogens. The neutropenic diet is one such intervention that was intended to reduce the introduction of bacteria into the host's gastrointestinal tract. This diet excludes foods considered to be high risk for bacterial colonization, especially raw fruits and vegetables. The only studies evaluating this diet have used this intervention in combination with germ free environments, which have been phased out of practice, and the independent effect of this diet remains unknown. In addition, pediatric oncology patients suffer significant gastrointestinal side effects secondary to cancer therapy, which are likely to affect their satisfaction with this dietary regimen. Qualitative data in these children suggests that decreased pleasure from food is a major concern for them and preliminary data on the neutropenic diet showed that although patients were able to stick to it, they found it difficult. The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) offer more liberalized food safety guidelines for immunocompromised patients. We hypothesize that the neutropenic dietary restrictions offer no advantage over the FDA and CDC endorsed food safety guidelines and that the food safety guidelines will afford patients an improved quality of life through increased choice and control over their diet. The results of this study could potentially modify clinical practice to improve the quality of life of these patients without adverse effects on their rate of infection. Furthermore, the allowance of fresh fruits and vegetables back into the diets of these patients may have a positive impact on their health.

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
Double (Participant, Care Provider)

入排标准

年龄范围
1 Year 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients between the ages of 1 and 30 years with:
  • •Acute lymphoblastic leukemia/lymphoma
  • •Malignant brain tumor
  • •Non-CNS solid tumors
  • •Acute myeloblastic leukemia
  • •Non-Hodgkin's lymphoma Hodgkin's disease
  • •Head and Neck tumors
  • •Patients MUST also be ready to receive a cycle of chemotherapy that predictably renders neutropenia at least 70% of the time OR has a risk of febrile neutropenia of at least 20%. This can be any cycle number, it does NOT need to be the FIRST cycle of chemotherapy they are to receive.

排除标准

  • •Patients receiving myeloablative chemotherapy in preparation for allogeneic or autologous bone marrow or stem cell transplant.
  • •Co-morbidity with immunosuppressive disease such as AIDS.
  • •Asplenia.
  • •Patients with documented infection at time of enrollment.
  • •Patients who are not fed orally (G-tube dependant, TPN-dependant).
  • •Patients actively receiving radiation to the brain or gastrointestinal tract for sarcoma.

研究组 & 干预措施

Neutropenic Diet

Active Comparator

Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.

干预措施: Food Safety Guidelines (Other)

Neutropenic Diet

Active Comparator

Participants will be instructed to follow a Neutropenic Diet. This group will receive the same information as the Food Safety Arm with some additional recommendations for avoiding high bacteria foods during length of time on study.

干预措施: Neutropenic Diet (Other)

FDA Food Safety Guidelines

Active Comparator

Participants will be instructed to follow the FDA Food Safety Guidelines

干预措施: Food Safety Guidelines (Other)

结局指标

主要结局

Neutropenic Infection

时间窗: approximately 4 weeks

次要结局

  • Quality of life(Baseline and at study end)
  • Documented Infection(approximately 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Moody

Director of Pediatric Palliative Care

Indiana University

研究点 (6)

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