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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
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.
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.
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGFeasibility of nutrition and exercise intervention
Percentage of eligible patients that consent to trial.
Time frame: End of study recruitment (approximately 1 year)
Adherence to dietary intervention
Percentage of participants that are "adherent", defined as \>75% of the patient's dietary assessments consistent with the prescribed diet.
Time frame: 22 days
Adherence to exercise intervention
Percentage of participants able to meet the exercise goal in 2 out of 3 weeks of induction therapy or 66% of their weeks of inpatient admission if admitted for more than 3 weeks.
Time frame: 22 days
Usability of interventions
To assess intervention usability, a 10-item questionnaire, the System Usability Scale Questionnaire, will be administered to each patient postintervention. This instrument rates responses from "strongly agree" to "strongly disagree". A score \>68 is considered of acceptable usability.
Time frame: 22 days
Body composition changes - Visceral Adiposity
Percent change in Visceral Adiposity from baseline to day 22 on study will be described. CT measurements of height-adjusted lumber adiposity area (VAT) are calculated from routine contrast and non-contrast CT scans of chest and abdomen
Time frame: 22 days
Body composition changes - Sarcopenia (SMI)
Percent change in sarcopenia score from baseline to day 22 on study will be described. Sarcopenia is loss of skeletal muscle mass and function associated with aging and will be calculated as mg/m2 measurements of skeletal muscle cross-sectional area, index, and radiation attenuation utilizing clinical computed tomography (CT) scans. The lower the value the worse the outcome.
Time frame: 22 days
Impact on minimal residual disease (MRD)
Number of participants that are MRD positive at end of induction therapy
Time frame: 22 days
Impact on Treatment toxicities
Number of participants that experience experience grade 3-4 hyperglycemia and hepatoxicity during induction. Adverse Events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) v5 criteria.
Time frame: 22 days
Changes to the Host Metabolome
Assessment of changes to the host metabolome throughout the intervention on daily serum samples (excluding weekends and holidays) will be assess descriptively
Time frame: 22 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.