Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)

Not Applicable

Active, not recruiting

• Conditions: Philadelphia Chromosome Negative; B Cell Acute Lymphoblastic Leukemia (B-ALL); B-ALL

• Registration Number: NCT06785324
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-21
• Status Verified: 2025-03
• Study Start: 2025-03-14
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-04-10
• Study Completion: 2028-04-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of nutrition and exercise intervention	End of study recruitment (approximately 1 year)	Percentage of eligible patients that consent to trial.

Secondary Outcome Measures

Name	Time	Method
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.
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
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.
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

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States