Clinical trial · Interventional
Pediatric Oncology Nutrition Intervention Trial
The Pediatric Oncology Interventional Nutrition Therapy (POINT) Trial: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition, Child | — | UNRESOLVED | — |
| Muscle Loss | — | UNRESOLVED | — |
| Nutrition Aspect of Cancer | — | UNRESOLVED | — |
| Nutrition Related Cancer | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyproheptadine | Drug | — | UNRESOLVED |
| Olanzapine | Drug | — | UNRESOLVED |
| Oral Nutrition Supplement | Dietary Supplement | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
| Tube Feed | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Standard of Care who have either weight gain, weight maintenance, or weight loss \<10%.
- interventionNames
- Other: Standard of Care
- type
- EXPERIMENTAL
- label
- Oral Nutrition Supplements
- description
- Those receiving ONS will be prescribed a standard ONS (1.0 kcal per mL) that will meet a minimum of 50% of estimated energy needs to promote weight gain but allow for continued regular dietary intakes. The ONS will be prescribed as 8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs.
- interventionNames
- Dietary Supplement: Oral Nutrition Supplement
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis of pediatric cancer Exclusion Criteria: * Current use or history of enteral nutrition, oral supplement, or orexigenic/anorectic use.
References
Publications (0)
Data not yet available