Nutrition and Exercise for Acute Lymphoblastic Leukemia

(NEOMA ALL Trial)

Overseen By Clinical Trials Intake

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Low BMI, Non-compliance, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how nutrition and exercise affect muscle and body fat in adults with Philadelphia Chromosome Negative B-ALL during hospital treatment. Participants will follow a nutrition plan and a physical exercise routine, with activity tracked by a Fitbit. It is ideal for those newly diagnosed with this condition and undergoing intensive chemotherapy. As an unphased trial, this study provides a unique opportunity to contribute to understanding lifestyle impacts on leukemia treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Past studies have shown that exercise programs for patients with acute lymphoblastic leukemia (ALL) are safe. Research indicates these programs yield positive results without major safety issues. Patients with ALL who participated in exercise programs improved their physical activity and motor skills.

In contrast, nutrition programs lack clear information about their safety. More high-quality studies are needed to better understand their safety and effectiveness. While researchers are investigating nutrition programs, more evidence is required to confirm their safety and benefits.

Overall, both exercise and nutrition programs are generally considered safe, but stronger evidence supports the safety of exercise programs for patients with ALL. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise interventions for Acute Lymphoblastic Leukemia (ALL) because they offer a holistic approach that complements traditional treatments like chemotherapy. Unlike conventional therapies that primarily focus on targeting cancer cells, these interventions aim to enhance the overall well-being and recovery of patients by promoting physical activity and optimal nutrition. This dual approach could potentially reduce treatment side effects, improve patients' quality of life, and support faster recovery, which are significant departures from the usual focus solely on eradicating cancer cells.

What evidence suggests that this trial's interventions could be effective for acute lymphoblastic leukemia?

Research shows that exercise is safe and beneficial for people with acute leukemia. Exercise can enhance fitness and reduce fatigue during and after treatment. Studies have found that staying active helps maintain mobility during chemotherapy.

Regarding nutrition, evidence suggests that eating the right foods can improve outcomes for people with acute lymphoblastic leukemia (ALL). Patients who follow personalized nutrition plans tend to live longer and experience fewer relapses. Good nutrition can also help manage weight and improve overall health during treatment.

In this trial, participants will receive both exercise and nutrition interventions while hospitalized for routine ALL treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Wendy Stock

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with a type of blood cancer called Philadelphia Chromosome Negative B-ALL. They must be hospitalized for initial treatment and able to participate in both nutrition and exercise interventions. Specific details on who can or cannot join are not provided.

Inclusion Criteria

I am undergoing a strong chemotherapy regimen designed for children.

My leukemia is newly diagnosed and does not have the Philadelphia chromosome.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants undergo inpatient induction therapy with nutrition and exercise interventions

3 weeks

Daily monitoring (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention
• Nutrition Intervention

Trial Overview

The study is testing how special diet plans and physical activity programs affect muscle mass and fat levels in patients. Participants will use a FitBit® to track their exercise during the hospital stay while receiving these interventions.

How Is the Trial Designed?

Group I: Nutrition and Exercise interventions Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

A pilot study involving 17 children aged 5 to 10 years with acute lymphoblastic leukemia showed that a 6-month home-based exercise intervention was feasible, with 71% of participants completing the program.

The exercise intervention led to significant improvements in physical abilities, including strength and flexibility, with 67% of participants showing enhanced knee strength and 83% improving ankle flexibility, indicating potential benefits for children undergoing cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. Esbenshade, AJ., Friedman, DL., Smith, WA., et al.[2022]

A study involving 33 patients with acute lymphoblastic leukemia (ALL) showed that cross-training and resistance exercises significantly improved body composition and physical performance compared to a control group, which experienced muscle loss and increased fat mass.

Despite the positive effects on body composition and physical performance, the quality of life (QOL) did not show significant differences among the groups, suggesting that while exercise is beneficial for physical health, it may not directly impact overall QOL during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Training and Resistance Training in Adults with Type B Acute Lymphoblastic Leukemia during the Induction Phase: A Randomized Blind Pilot Study. Gallardo-Rodríguez, AG., Fuchs-Tarlovsky, V., Ocharán-Hernández, ME., et al.[2023]

The IDEAL trial, involving 40 patients aged 10 to 21 with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL), showed that a diet and exercise intervention did not significantly reduce overall fat mass gain but effectively reduced fat gain in overweight/obese patients by 8.2% (from +9.7% to +1.5%).

The intervention also significantly decreased the risk of minimal residual disease (MRD) after chemotherapy, with an odds ratio of 0.30, suggesting that caloric restriction through diet and exercise may enhance chemotherapy efficacy in B-ALL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Orgel, E., Framson, C., Buxton, R., et al.[2022]

A 6-month dietary intervention focusing on a low glycemic diet was successfully implemented in 23 participants with childhood acute lymphoblastic leukemia (ALL), showing significant reductions in sugar intake and increases in vegetable consumption.

The intervention effectively prevented weight gain during the initial treatment phase for ALL, with no increase in body mass index z-scores observed, suggesting it is a feasible approach to manage obesity risks in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bilingual dietary intervention early in treatment is feasible and prevents weight gain in childhood acute lymphoblastic leukemia. Walters, M., Mowbray, C., Jubelirer, T., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8359930/

The effect of exercise and motor interventions on physical ...

Medical intervention for ALL has improved dramatically over the past decade, resulting in a 5-year survival rate of 90.4%.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1040842820301426

The effect of exercise and motor interventions on physical ...

Exercise and motor interventions result in improved physical activity and motor outcomes for children with ALL during and after chemotherapy. •. Acute: Fatigue ...

3.

nature.com

nature.com/articles/s41598-025-89703-9

Changes in physical fitness in acute leukemia patients ...

Previous research has shown that exercise interventions can be safe and effective in improving patients' fitness levels with AL. Aerobic ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4211618/

Feasibility and Initial Effectiveness of Home Exercise ...

This pilot study demonstrated that exercise intervention during ALL therapy is feasible and has promise for efficacy. Keywords: acute lymphoblastic leukemia/ ...

5.

frontiersin.org

frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.982996/full

Effects of strength exercise interventions on activities ...

Patients with leukemia reduce their daily step counts by 70% compared with healthy peers during inpatient stays (8). As a consequence, the ...

6.

cancer.jmir.org

cancer.jmir.org/2021/2/e25569/

Home-Based Telehealth Exercise Intervention in Early-On ...

Only a few studies have addressed the effects of home-based exercise interventions on muscle function of children with acute lymphoblastic ...

7.

epistemonikos.org

epistemonikos.org/es/documents/e850a474ef3731fe39756f8394ef5c912a20b9a1

Effects of Exercise Intervention for Children with Acute ...

Results:: Across all studies, therapeutic exercise was a safe intervention for patients with ALL, with each study noting positive outcomes.