Actively Recruiting
Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With Philadelphia Chromosome Negative B-ALL During Hospitalized Induction Therapy
Led by University of Chicago · Updated on 2025-06-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how nutrition and exercise affect muscle and body fat in adults with Philadelphia Chromosome Negative B-Cell Acute Lymphoblastic Leukemia (B-ALL) who are undergoing intensive inpatient induction chemotherapy. The trial aims to study these interventions during hospital treatment to understand their feasibility and impact on body composition and treatment outcomes. Participants will receive two main interventions: a nutrition intervention and a physical exercise intervention. The nutrition plan focuses on a 10% calorie reduction based on each patient’s metabolic rate, using a high-protein, low-fat, and high-fiber diet. A dietician will guide patients on dietary choices and monitor adherence every two days, excluding weekends. The exercise intervention targets 200 minutes of moderate aerobic and resistance activity weekly, customized by a physical therapist who evaluates patients every 48 hours, excluding weekends. All participants will wear a Fitbit® to track activity levels. During the study, patients will be monitored for adherence to the diet and exercise plans, changes in body fat and muscle mass, minimal residual disease, treatment side effects, and metabolic changes. The trial lasts approximately 22 days during the induction treatment phase. Researchers will assess the feasibility of these interventions over about one year of recruitment. Safety and progress will be closely observed throughout the study period.
CONDITIONS
Brief Title
Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of Philadelphia Chromosome Negative B-Cell Acute Lymphoblastic Leukemia
- Receiving intensive pediatric-inspired induction chemotherapy
- Aged between 18 and 50 years
You will not qualify if you...
- Body mass index (BMI) less than 18.5 kg/m2 at diagnosis
- Unable to follow both the recommended diet and exercise program as judged by the research or treatment team
- Pregnant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 22 days
Participants receive nutrition and exercise interventions while hospitalized for routine treatment of acute lymphoblastic leukemia. The nutrition intervention involves a diet targeting a 10% caloric deficit with high protein and low fat, monitored by a dietician every two days excluding weekends. The exercise intervention targets 200 minutes of moderate physical activity weekly, with physical therapist evaluations every 48 hours excluding weekends.
Dietician visits every two days and physical therapist visits every 48 hours, excluding weekends
Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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