B-ALL, B Cell Acute Lymphoblastic Leukemia (B-ALL), Philadelphia Chromosome Negative
Conditions
Brief 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.
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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of nutrition and exercise intervention | End of study recruitment (approximately 1 year) | Percentage of eligible patients that consent to trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to exercise intervention | 22 days | 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. |
| Usability of interventions | 22 days | 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. |
| Body composition changes - Visceral Adiposity | 22 days | 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 |
| Adherence to dietary intervention | 22 days | Percentage of participants that are adherent, defined as \>75% of the patient's dietary assessments consistent with the prescribed diet. |
| Impact on minimal residual disease (MRD) | 22 days | Number of participants that are MRD positive at end of induction therapy |
| Impact on Treatment toxicities | 22 days | 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. |
| Changes to the Host Metabolome | 22 days | Assessment of changes to the host metabolome throughout the intervention on daily serum samples (excluding weekends and holidays) will be assess descriptively |
| Body composition changes - Sarcopenia (SMI) | 22 days | 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. |
Countries
United States
Contacts
Primary ContactClinical Trials Intake
Outcome results
None listed