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Appetite Stimulants 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
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
POINT Trial 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.Check my eligibility
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.See study design
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.
POINT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has recently been diagnosed with cancer.
POINT Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Composition
Secondary outcome measures
Biomarkers
Change in BMI
Change in weight
+6 morePOINT 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 dronabinol. Subjects will be given cyproheptadine if they fall between the ages of 2-12 years of age and dronabinol 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
Dronabinol
2003
Completed Phase 4
~2080
Oral Nutrition Supplement
2016
N/A
~30
Cyproheptadine
2011
Completed Phase 4
~330
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
401,718 Total Patients Enrolled
Corey HawesLead Sponsor
Corey J Hawes, DCN, RD, CSO, CNSC, LDPrincipal InvestigatorUniversity of Kentucky, Kentucky Children's Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical research allow for the participation of geriatric individuals?
"As indicated by the criteria for inclusion, only individuals between 2 and 19 years old are eligible to participate in this trial. Furthermore, there are 122 studies available for minors and 125 trials targeting seniors over 65."
Answered by AI
Is it possible for me to join this investigation?
"In order to participate in this investigation, participants must exhibit muscular atrophy and be between the ages of two and nineteen. A total of 45 candidates are currently sought for this study."
Answered by AI
Are there any unfilled slots in this research experiment available to participants?
"Clinicaltrials.gov verifies that this trial is not currently seeking new participants, having been originally posted on January 1st 2024 and last updated December 14th 2023. Fortunately, there are 243 other trials actively recruiting patients right now."
Answered by AI
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