NCT06785324

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
May 2025Nov 2027

First Submitted

Initial submission to the registry

December 23, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2027

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.5 years

First QC Date

December 23, 2024

Last Update Submit

June 18, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Feasibility of nutrition and exercise intervention

    Percentage of eligible patients that consent to trial.

    End of study recruitment (approximately 1 year)

Secondary Outcomes (8)

  • Adherence to dietary intervention

    22 days

  • Adherence to exercise intervention

    22 days

  • Usability of interventions

    22 days

  • Body composition changes - Visceral Adiposity

    22 days

  • Body composition changes - Sarcopenia (SMI)

    22 days

  • +3 more secondary outcomes

Study Arms (1)

Nutrition and Exercise interventions

EXPERIMENTAL

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

Behavioral: Nutrition InterventionBehavioral: Exercise intervention

Interventions

Nutrition InterventionBEHAVIORAL

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.

Nutrition and Exercise interventions
Exercise interventionBEHAVIORAL

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.

Nutrition and Exercise interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • New Diagnosis of Philadelphia Chromosome Negative B-ALL
  • Receiving intensive pediatric-inspired induction chemotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Wendy Stock

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 21, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

November 6, 2027

Study Completion (Estimated)

November 6, 2027

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations

US(1)