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NCT Number: NCT06785324

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

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.

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Key information

Conditions

Philadelphia Chromosome Negative B Cell Acute Lymphoblastic Leukemia (B-ALL) B-ALL Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Clinical Trials intake

CONTACT

[email protected]

855-702-8222

Wendy Stock

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Intervention

Behavioral

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

Behavioral

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 outcomes

  1. Feasibility of nutrition and exercise intervention

    Time frame: End of study recruitment (approximately 1 year)

    Percentage of eligible patients that consent to trial.

Secondary outcomes

  1. Adherence to dietary intervention

    Time frame: 22 days

    Percentage of participants that are "adherent", defined as >75% of the patient's dietary assessments consistent with the prescribed diet.

  2. Adherence to exercise intervention

    Time frame: 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.

  3. Usability of interventions

    Time frame: 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.

  4. Body composition changes - Visceral Adiposity

    Time frame: 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

  5. Body composition changes - Sarcopenia (SMI)

    Time frame: 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.

  6. Impact on minimal residual disease (MRD)

    Time frame: 22 days

    Number of participants that are MRD positive at end of induction therapy

  7. Impact on Treatment toxicities

    Time frame: 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.

  8. Changes to the Host Metabolome

    Time frame: 22 days

    Assessment of changes to the host metabolome throughout the intervention on daily serum samples (excluding weekends and holidays) will be assess descriptively

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial

Acronym: NEOMA ALL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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