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

Trial Summary

What is the purpose of this 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.

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.

What data supports the effectiveness of the treatment Exercise Intervention, Nutrition Intervention for Acute Lymphoblastic Leukemia?

Research shows that exercise programs can improve physical performance and body composition in children and adults with acute lymphoblastic leukemia (ALL). These improvements are important because they help counteract the negative effects of cancer treatment, such as muscle loss and decreased physical capacity. ^{1 2 3 4 5}

Is the Nutrition and Exercise treatment safe for humans?

Research shows that exercise and nutrition interventions are generally safe for children with acute lymphoblastic leukemia (ALL). Studies have found these interventions feasible and effective in managing weight and improving health during and after treatment. ^{1 2 3 6 7}

How does the Nutrition and Exercise treatment for Acute Lymphoblastic Leukemia differ from other treatments?

This treatment is unique because it combines dietary interventions and exercise to manage weight and improve physical performance during leukemia treatment, which can help reduce treatment-related side effects and improve chemotherapy effectiveness. Unlike traditional treatments that focus solely on medication, this approach addresses obesity and physical deconditioning, which are common issues in leukemia patients. ^{1 2 4 6 8}

Research Team

Wendy Stock

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of acute exercise on neutrophils in pediatric acute lymphoblastic leukemia survivors: a pilot study. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and initial effectiveness of home exercise during maintenance therapy for childhood acute lymphoblastic leukemia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development, feasibility and efficacy of a community-based exercise training program in pediatric cancer survivors. [2009]

4. Switzerland 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of exercise on lower activity levels in children with acute lymphoblastic leukemia: a randomized controlled trial from Turkey. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

A bilingual dietary intervention early in treatment is feasible and prevents weight gain in childhood acute lymphoblastic leukemia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. [2022]