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Nutrition Interventions for Pediatric Cancer (POINT Trial)

Phase 2 & 3

Recruiting

Led By Corey J Hawes, DCN, RD, CSO, CNSC, LD

Research Sponsored by Corey Hawes

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New diagnosis of pediatric cancer

Be younger than 65 years old

Must not have

Current use or history of orexigenic/anorectic use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at 3 and 6 months from baseline for control group. those randomized will receive measurements at randomization and 1 & 3 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will research ways to help pediatric cancer patients get proper nutrition to reduce risk of infection, treatment-related toxicity, inferior outcomes, & mortality.

Who is the study for?

This trial is for children newly diagnosed with cancer who haven't used enteral nutrition, oral supplements, or appetite stimulants before. It aims to help those at risk of malnutrition due to the effects of their illness and treatment.

What is being tested?

The study tests how different nutritional strategies affect body composition and weight in pediatric cancer patients. It compares oral supplements, appetite drugs like Dronabinol and Cyproheptadine, tube feeding, and standard care.

What are the potential side effects?

Possible side effects may include changes in appetite or mood from Dronabinol (a cannabis-based medicine), stomach discomfort from tube feeding, drowsiness or increased hunger from Cyproheptadine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has recently been diagnosed with cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have used or am using appetite-altering drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at 3 and 6 months from baseline for control group. those randomized will receive measurements at randomization and 1 & 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at 3 and 6 months from baseline for control group. those randomized will receive measurements at randomization and 1 & 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 3 and 6 months from baseline for control group. those randomized will receive measurements at randomization and 1 & 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Composition

Secondary study objectives

Biomarkers

Change in BMI

Change in weight

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Oral Nutrition SupplementsExperimental Treatment1 Intervention

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.

Group II: Enteral NutritionExperimental Treatment1 Intervention

Those randomized to EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs to allow for continued regular dietary intakes during the day.

Group III: Appetite StimulantsExperimental Treatment2 Interventions

Those receiving age-appropriate appetite stimulants will be provided either cyproheptadine or olanzapine. Subjects will be given cyproheptadine if they fall between the ages of 2-12 years of age and olanzapine if they are \>12 years of age or older.

Group IV: ControlActive Control1 Intervention

Standard of Care who have either weight gain, weight maintenance, or weight loss \<10%.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olanzapine

2005

Completed Phase 4

~5480

Cyproheptadine

2011