Philadelphia Chromosome NegativeNEOMA ALLNCT06785324
Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
A study testing Nutrition Intervention and Exercise intervention in people with Philadelphia Chromosome Negative and B Cell Acute Lymphoblastic Leukemia (B-ALL), run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Philadelphia Chromosome Negative, B Cell Acute Lymphoblastic Leukemia (B-ALL), B-ALL
- What is being tested?
- Nutrition Intervention and Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 6 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- New Diagnosis of Philadelphia Chromosome Negative B-ALL
- Receiving intensive pediatric-inspired induction chemotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Wendy Stock
About this study
Official title: Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
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.
- Being tested
- Nutrition Intervention, Exercise intervention
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition InterventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Exercise interventions | Experimental | Participants will receive an exercise and nutrition (diet) intervention while hospitalized for routine treatment for their ALL. Receives: Behavioral: Nutrition Intervention; Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of nutrition and exercise intervention
Percentage of eligible patients that consent to trial.
Measured: End of study recruitment (approximately 1 year)
Secondary outcomes (8)
Adherence to dietary intervention
Percentage of participants that are "adherent", defined as >75% of the patient's dietary assessments consistent with the prescribed diet.
Measured: 22 days
Adherence to exercise intervention
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.
Measured: 22 days
Usability of interventions
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.
Measured: 22 days
Body composition changes - Visceral Adiposity
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
Measured: 22 days
Body composition changes - Sarcopenia (SMI)
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.
Measured: 22 days
Impact on minimal residual disease (MRD)
Number of participants that are MRD positive at end of induction therapy
Measured: 22 days
Impact on Treatment toxicities
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.
Measured: 22 days
Changes to the Host Metabolome
Assessment of changes to the host metabolome throughout the intervention on daily serum samples (excluding weekends and holidays) will be assess descriptively
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start12 May 2025
- Primary completion6 Nov 2027 (estimated)
- Study completion6 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome NegativeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785324
- Sponsor's protocol ID
- IRB24-1500
- Acronym
- NEOMA ALL
- Status last verified
- Jun 2025
- First submitted
- 23 Dec 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided