Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutrition Intervention, Exercise intervention.
- Who it may be relevant to
- Registry conditions: Philadelphia Chromosome Negative, B Cell Acute Lymphoblastic Leukemia (B-ALL), B-ALL. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
Overview
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)]
Secondary outcome measures (8)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Chicago Medicine Comprehensive Cancer Center — Chicago
Identifiers
NCT: NCT06785324 · IRB24-1500