NCT06785324 · University of Chicago
Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
(NEOMA ALL)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Feasibility of nutrition and exercise intervention
Time frame: End of study recruitment (approximately 1 year)
Percentage of eligible patients that consent to trial.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 19, 2025 · Source of record for eligibility and locations