Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT06785324Sponsor: University of ChicagoLast updated: 2025-06-19

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

Sex: AllAge: 18 Years to 50 YearsHealthy volunteers: No
Inclusion Criteria: * New Diagnosis of Philadelphia Chromosome Negative B-ALL * Receiving intensive pediatric-inspired induction chemotherapy Exclusion Criteria: * BMI ≤18.5 kg/m2 at time of diagnosis * Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team * Pregnant

Study locations (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

Recruiting
Clinical Trials intake · Contact
Wendy Stock · Principal Investigator
Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL) | Cancerify