Pediatric Oncology Nutrition Intervention Trial
Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival. The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.
Conditions:
🦠 Pediatric Cancer 🦠 Nutrition Related Cancer 🦠 Nutrition Aspect of Cancer 🦠 Muscle Loss 🦠 Malnutrition, Child
🗓️ Study Start (Actual) 31 January 2024
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 45
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Lexington, Kentucky, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * New diagnosis of pediatric cancer

    Exclusion Criteria:

    • * Current use or history of enteral nutrition, oral supplement, or orexigenic/anorectic use.
Ages Eligible for Study: 2 Years to 19 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 November 2023
  • First Submitted that Met QC Criteria 14 December 2023
  • First Posted 18 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024