This clinical trial studies three nutritional interventions in preventing weight loss in pediatric patients with cancer. During treatment for pediatric cancer, many patients will have changes in their weight. It is not well known how diet changes to prevent weight loss affect body changes in muscle and fat, or which treatment types are best. There are three options that are usually used: nutrition supplements, which are usually high-calorie drinks that can be added to a child's diet; appetite stimulants, which are medications given to boost a child's appetite; or what is called enteral feeds, which is feeding a child with a liquid formula through a tube that runs from their nose to their stomach. This trial may help researchers learn how body composition changes throughout therapy and how nutrition interventions alter body composition. Additionally, these results could tell researchers which nutrition interventions are the best to use during therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06175273.
PRIMARY OBJECTIVE:
I. 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.
SECONDARY OBJECTIVE:
I. To utilize the findings to develop clinical nutrition guidelines in this patient population.
OUTLINE: All patients receive standard of care (SOC) medical nutrition therapy (MNT) counseling at diagnosis for following a high protein/high calorie diet. All patients also undergo ultrasound and blood sample collection at the time of enrollment. Patients who maintain their diagnosis weight or gain weight are assigned to Arm I. Patients who lose ≥ 10% of diagnosis weight are randomized to Arms II, III, or IV.
ARM I: Patients continue receiving SOC MNT and undergo ultrasounds at 3 and 6 months.
ARM II: Patients receive oral (PO) nutrition supplements (ONS) at least once a day (QD), but up to six times daily. ONS therapy continues until patients regain pre-randomization weight, the completion of cancer therapy, completion of ultrasounds and biomarker measurements, or in the absence of unacceptable toxicity. Patients also undergo ultrasound and blood sample collection at the time of randomization and at 1 and 3 months.
ARM III: Patients between 2-12 years of age receive cyproheptadine PO, and patients ≥ 12 years of age receive olanzapine PO. Cyproheptadine and olanzapine therapy continues until patients regain pre-randomization weight, the completion of cancer therapy, completion of ultrasounds and biomarker measurements, or in the absence of unacceptable toxicity. Patients also undergo ultrasound and blood sample collection at the time of randomization and at 1 and 3 months.
ARM IV: Patients receive enteral nutrition via a nasogastric feeding tube. Enteral nutrition continues until patients regain pre-randomization weight, the completion of cancer therapy, completion of ultrasounds and biomarker measurements, or in the absence of unacceptable toxicity. Patients also undergo ultrasound and blood sample collection at the time of randomization and at 1 and 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorCorey Hawes
