Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
NCT ID NCT05082519
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests whether a personalized diet and exercise plan during the first month of chemotherapy can make leukemia cells more sensitive to treatment in older children, adolescents, and young adults with B-cell acute lymphoblastic leukemia (B-ALL). The study also aims to reduce the body fat gain that often occurs during chemo, which is linked to drug resistance. Participants are randomly assigned to either receive the diet and exercise intervention alongside standard chemo or standard chemo alone. The goal is to see if this approach can lower the chance of leftover leukemia cells after induction therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A personalized diet and exercise program (caloric restriction and physical activity)
- What this could lead to
- If effective, this approach could make chemotherapy more powerful against leukemia and reduce treatment-related weight gain, potentially improving outcomes for young patients.
- What could go wrong
- This is an early-phase trial, and the diet/exercise plan may be hard to follow or may not meaningfully change chemotherapy response. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Aug 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be ≥ 7.0 and \<26.0 years of age. * Patients must have a diagnosis of de novo B-ALL * Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair). * The treatment regimen must be the first treatment attempt for B-ALL- * Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration \<35 days. * Organ function must meet that required for initiation of chemotherapy * Patients at diagnosis must meet Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) . * If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment. Exclusion Criteria: * Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in patients 20-29 years). * Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded. * Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded. * Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy. * Patients will be excluded if they received treatment for a previous malignancy. * Patient will be excluded if they are pregnant. * Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation . * Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia) * Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Baylor Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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C.S. Mott University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Children's Healthcare of Atlanta at Egleston
NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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Children's Hospital Los Angeles
RECRUITINGLos Angeles, California, 90027, United States
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Children's Hospital Orange County
RECRUITINGOrange, California, 92868, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Hospitals and Clinics of Minnesota
RECRUITINGMinneapolis, Minnesota, 55404, United States
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Children's Mercy Hospital
RECRUITINGKansas City, Kansas, 64108, United States
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Colorado Children's Hospital
RECRUITINGDenver, Colorado, 80045, United States
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Levine Children's Hospital
RECRUITINGCharlotte, North Carolina, 28203, United States
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Oregon Health & Science University
RECRUITINGPortland, Oregon, 97239, United States
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Primary Children's Hospital
RECRUITINGSalt Lake City, Utah, 84113, United States
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UCSF School of Medicine
RECRUITINGSan Francisco, California, 94158, United States
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University of Texas, Southwestern
RECRUITINGDallas, Texas, 75235, United States
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