Recruiting

Nutrition & Exercise

Sponsor:

University of Chicago

Code:

NCT06785324

Conditions

Philadelphia Chromosome Negative

B Cell Acute Lymphoblastic Leukemia (B-ALL)

B-ALL

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Nutrition Intervention

Exercise intervention

Study Details

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.

Conditions

Philadelphia Chromosome Negative

B Cell Acute Lymphoblastic Leukemia (B-ALL)

B-ALL

Study ID

NCT06785324

Start date

May 12, 2025

Status verified date

Jun, 2025

Completion date

Nov 6, 2027

Anticipated

Primary completion date

Nov 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nutrition and Exercise interventions

Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL.

Interventions

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.

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 measure

  • Feasibility of nutrition and exercise intervention [ Time Frame: End of study recruitment (approximately 1 year) ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Wendy Stock

More Information

Sponsor

University of Chicago

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-06-19.