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

NCT ID: NCT06785324

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-11-06

Brief Summary

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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

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Conditions

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Philadelphia Chromosome Negative B Cell Acute Lymphoblastic Leukemia (B-ALL) B-ALL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutrition and Exercise interventions

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

Group Type EXPERIMENTAL

Nutrition Intervention

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Stock

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Intake

Role: CONTACT

1-855-702-8222

Facility Contacts

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Clinical Trials intake

Role: primary

855-702-8222

Other Identifiers

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IRB24-1500

Identifier Type: -

Identifier Source: org_study_id

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