NCT06785324

Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)

Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy. Participants will take part in 2 different interventions: * Nutrition Intervention * Physical Exercise Intervention All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.

Conditions

• Philadelphia Chromosome Negative
• B Cell Acute Lymphoblastic Leukemia (B-ALL)
• B-ALL

Interventions

Type	Name	Description
BEHAVIORAL	Nutrition Intervention	The nutrition intervention will target a 10% caloric deficit calculated from each patient's Basal Metabolic Rate (WHO/Schofield) utilizing a high protein (\>25%), low fat (\<25%), low glycemic index/high fiber (45-55%) diet. The study registered dietician (RD) will meet with the patient on day of enrollment to go over the "menu" of dietary options and will re-assess the patient every two days (excluding weekends) for adherence. My Plate (USDA) will control portion size and eating habits.
BEHAVIORAL	Exercise intervention	The exercise intervention will target 200 minutes of "moderate" physical activity weekly, as defined by Metabolic Equivalents (METs) of 3-6, made up of aerobic and resistance training activities tailored to the patient's preference by working with the study physical therapist (PT). Physical Therapist to evaluate patient every 48 hours, excluding weekends.

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-11-06
• Completion: 2027-11-06
• First posted: 2025-01-21
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States