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Spots Global Cancer Trial Database for The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

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Trial Identification

Brief Title: The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Official Title: The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients

Study ID: NCT00726934

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Rady Children's Hospital San Diego, San Diego, California, United States

Riley Hospital for Children at IU Health, Indianapolis, Indiana, United States

Children's Hospital at Montefiore, Bronx, New York, United States

Maimonides Medical Center, Brooklyn, New York, United States

NYU Langone Medical Center, New York, New York, United States

Mount Sinai Medical Center, New York, New York, United States

Contact Details

Name: Karen Moody, MD, MS

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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