Pediatric Cancer Clinical Trial
— POINTOfficial title:
The Pediatric Oncology Interventional Nutrition Therapy (POINT) Trial: A Pilot Study
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | July 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 19 Years |
Eligibility | Inclusion Criteria: - New diagnosis of pediatric cancer Exclusion Criteria: - Current use or history of enteral nutrition, oral supplement, or orexigenic/anorectic use. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Corey Hawes | National Center for Advancing Translational Sciences (NCATS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Composition | Change in body composition will be measured by ultrasound of the quadricep muscle layer thickness in millimeters. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Primary | Body Composition | Change in body composition will be measured by mid-upper arm circumference via z-scores by measuring the mid-upper arm in centimeters and comparing to CDC standards. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Intolerances to interventions | These will be measured by CTCAEs to determine grade toxicity from interventions. | Those randomized to a treatment group, will receive measurements at randomization and 1 & 3 months. | |
Secondary | Change in weight | This will be measured with weight in kilograms and will be combined with data from CDC standardized growth charts to provide the weight z-score. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Change in BMI | This will be measured with pediatric z-scores for BMI and weight/length z-scores. Weight in kilograms and height in cm will be combined to report BMI in kg/m^2 and then plotted on CDC growth charts for z-scores. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Biomarkers | These biomarkers will be measured via central venous lines, including IL-6 (pg/mL) | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Biomarkers | These biomarkers will be measured via central venous lines, including leptin (ng/mL) and vitamin D (ng/mL). | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Biomarkers | These biomarkers will be measured via central venous lines, including lipid profile (mg/dL). | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Biomarkers | These biomarkers will be measured via central venous lines, including cystatin-c (mg/L) and CRP (mg/L). | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Physical Activity | Physical activity will be measured by team assessment of Lanksy Play-Performance Scale for Pediatric Functional Status. This scale uses parent descriptions of child's activity to assess ability and response to treatment. Scale ranges from 0-100 with a higher score indicating greater activity. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Tube feeding compliance | Compliance will be analyzed by self-reported weekly compliance tube feeding volume which will be measured by the change in volume in mL compared to prescribed amounts in mL. | Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Oral nutrition supplements compliance | Compliance will be analyzed by self-reported weekly compliance oral nutrition supplements which will be measured by the change in volume in number of cans compared to prescribed amounts in number of cans. | Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Medication compliance | Compliance will be analyzed by self-reported weekly compliance of medication consumption which will be measured by the change in days all prescribed medications were taken compared to days where less medications than prescribed were taken. | Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the number of days hospitalized for nutrition-related issues | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the number of clinic visits for nutrition-related issues | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include if they have a diagnosis of malnutrition (yes/no). | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the rate of relapse or progression (yes/no) | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the number of days that cancer treatment is put on hold. | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the presence of chemotherapy toxicities using CTCAE (Common Terminology Criteria for Adverse Events) grading scale (grades 1-4) | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. | |
Secondary | Clinical measures | These measurements will include the diagnosis type (cancer type). | Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months. |
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