Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
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.
Arms & interventions
- BehavioralNutrition 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.
- BehavioralExercise 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.
Outcome measures
Primary
Feasibility of nutrition and exercise intervention
Percentage of eligible patients that consent to trial.
Time frame: End of study recruitment (approximately 1 year)
Secondary
Adherence to dietary intervention
Time frame: 22 days
Adherence to exercise intervention
Time frame: 22 days
Usability of interventions
Time frame: 22 days
Body composition changes - Visceral Adiposity
Time frame: 22 days
Body composition changes - Sarcopenia (SMI)
Time frame: 22 days
Impact on minimal residual disease (MRD)
Time frame: 22 days
Impact on Treatment toxicities
Time frame: 22 days
Changes to the Host Metabolome
Time frame: 22 days
Eligibility criteria
Study locations (1)
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637