PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management

(PEDALL Trial)

Overseen By Pooja Vyas, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Nutrition support, Eating disorder, others

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

Compensation: Varies

Number of Visits: 26

Duration: 6 months

376 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an online nutrition education program called PEDALL for children and teens with acute lymphoblastic leukemia (ALL) who are undergoing maintenance chemotherapy. The goal is to prevent them from becoming overweight or obese, which is a common issue during treatment. By teaching healthy eating habits and providing regular support, the program aims to help these young patients maintain a healthy weight.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on dietary education during chemotherapy, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the PEDALL treatment for weight management in children with acute lymphoblastic leukemia?

Research shows that lifestyle interventions, including exercise and dietary changes, can help manage weight in children with acute lymphoblastic leukemia. A study found that a 12-week lifestyle program helped children improve their diet, suggesting that similar interventions like PEDALL could be effective in preventing weight gain. ^{1 2 3 4 5}

Is the PEDALL Program for Childhood Acute Lymphoblastic Leukemia Weight Management safe for children?

Exercise interventions for pediatric cancer patients, including those with leukemia, have shown good adherence and no adverse events, suggesting they are generally safe for children. ^{1 3 6 7 8}

How is the PEDALL treatment different from other treatments for childhood acute lymphoblastic leukemia?

The PEDALL treatment is unique because it focuses on preventing weight gain in children with acute lymphoblastic leukemia through a bilingual, virtually-based lifestyle intervention, which includes web-based sessions and phone calls with a lifestyle coach. This approach is different from traditional treatments that primarily focus on medical interventions, as it emphasizes early lifestyle changes to manage weight and improve long-term health outcomes. ^{1 2 3 9 10}

Research Team

Elena Ladas, PhD, RD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for children and young adults aged 5-21 fluent in English or Spanish, diagnosed with B- or T-cell ALL or mixed phenotype acute leukemia. They must be starting maintenance chemotherapy, have a healthy weight (specific BMI criteria), and can be of any race. Those on nutrition support or with eating disorders cannot participate.

Inclusion Criteria

I am undergoing or planning to undergo maintenance chemotherapy for acute lymphoblastic leukemia.

Ethnicity: Hispanic or Non-Hispanic of any race

I can start the study treatment within the first month of my maintenance therapy for ALL.

Exclusion Criteria

I am receiving nutrition through a feeding tube or IV.

Patients with a history of eating disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a six-month virtually-delivered dietary education intervention (PEDALL) during maintenance chemotherapy

6 months

26 virtual visits (once weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including BMI z-score trajectories over time

1 year post-treatment

Treatment Details

Interventions

• PEDALL

Trial Overview The study tests the PEDALL program—a six-month virtual dietary education—against standard care to prevent overweight and obesity during maintenance chemotherapy in young patients with acute lymphoblastic leukemia.

Participant Groups

Group I: PEDALL Experimental Treatment 1 Intervention

The intervention group (PEDALL) will receive twenty-six contact hours of virtually-delivered nutrition education. Participants and/or caregivers will meet with their nutrition educator once weekly for one hour for six months.

Group II: Standard of Care (SOC) Active Control 1 Intervention

Subjects randomized to SOC will receive printed educational materials at study entry and will continue to receive nutritional education/care per their institution's standards of care.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

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 12-week remote lifestyle intervention for 15 children with pediatric acute lymphoblastic leukemia (ALL) showed promising results, with 86.7% of families completing the program.

The intervention led to positive dietary changes, such as increased milk and protein intake and reduced consumption of potatoes, although it did not significantly affect physical activity levels, BMI, or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. Zhang, FF., Kelly, M., Du, M., et al.[2020]

An exercise program during cancer treatment may help improve physical health and quality of life for pediatric patients, although evidence specifically for this group is still limited.

This review analyzed eight randomized controlled trials focused on exercise programs for children undergoing leukemia and lymphoma treatment, highlighting the need to address biases in studies to ensure reliable recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review. Zucchetti, G., Rossi, F., Chamorro Vina, C., et al.[2019]

In a study of 141 Hispanic pediatric patients with B-precursor acute lymphoblastic leukemia (ALL), BMI scores increased steadily during the first 12 months of chemotherapy, indicating a significant risk of weight gain during treatment.

The increase in BMI was most pronounced in patients who were normal weight at diagnosis, while those who were overweight or obese showed more stable or slightly declining BMI patterns, suggesting that normal-weight children are particularly vulnerable to chemotherapy-related weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy-related changes in body size in Hispanic children with acute lymphoblastic leukemia. Baillargeon, J., Langevin, AM., Lewis, M., et al.[2021]

In a study of 327 childhood cancer patients, the prevalence of overweight increased from 8% at diagnosis to 13% by the end of treatment, indicating a significant risk of weight gain during cancer therapy.

Boys and those diagnosed with acute lymphoblastic leukaemia (ALL) or lymphoma were identified as having a higher risk of weight gain, suggesting that targeted lifestyle interventions may be beneficial for these groups during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight in childhood cancer patients at diagnosis and throughout therapy: A multicentre cohort study. Belle, FN., Wenke-Zobler, J., Cignacco, E., et al.[2020]

Exercise interventions for pediatric cancer patients during inpatient treatment show good adherence and positive trends in health status, based on a review of 10 studies involving 204 patients.

No adverse events were reported, suggesting that physical activity programming can be safely integrated into the care of pediatric oncology inpatients to help mitigate the negative effects of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Rustler, V., Hagerty, M., Daeggelmann, J., et al.[2022]

Oral nutrition supplements (ONSs) and appetite stimulants can improve weight status in pediatric patients with malignancies, as shown in six trials that included various types of cancers.

Despite the positive outcomes, the studies did not evaluate overall nutrition intake or adherence to ONS use, indicating a need for further research to determine the most effective strategies for weight management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of oral nutrition supplements and appetite stimulants on weight status among pediatric cancer patients: A systematic review. Hawes, C., Gomes, A., Byham-Gray, L., et al.[2023]

The enhanced physical activity (EPA) intervention was successfully implemented in 85.4% of scheduled sessions for 29 hospitalized children and adolescents undergoing treatment for solid tumors or acute myeloid leukemia, indicating its feasibility in a clinical setting.

While the ANOVA analysis suggested a trend towards improved sleep efficiency in the EPA group compared to controls, mixed model analysis did not show significant differences in sleep duration or efficiency, highlighting the need for careful statistical design in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. Hinds, PS., Hockenberry, M., Rai, SN., et al.[2007]

This scoping review analyzed 9 studies on malnutrition in pediatric cancer treatment, revealing that various nutritional interventions, such as appetite stimulants and supplements, can lead to improved weight outcomes, although the specific methods used showed no significant differences in effectiveness.

The review highlighted a lack of standardized definitions and screening tools for malnutrition, indicating that while some screening methods may reduce malnutrition risk and improve weight gain, there is a critical need for consistent assessment and treatment strategies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. Franke, J., Bishop, C., Runco, DV.[2022]

An aerobic exercise program significantly improved the quality of life in children with acute lymphoblastic leukemia undergoing chemotherapy, particularly in reducing pain and injury (p=0.002).

Parents reported improvements in their children's quality of life, especially regarding pain and cognitive issues at school, indicating that regular exercise can enhance overall wellbeing during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an aerobic exercise program on the quality of life in children with cancer. Khodashenas, E., Badiee, Z., Sohrabi, M., et al.[2019]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Early Lifestyle Intervention for Obesity Prevention in Pediatric Survivors of Acute Lymphoblastic Leukemia. [2020]

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

Exercise program for children and adolescents with leukemia and lymphoma during treatment: A comprehensive review. [2019]

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

Therapy-related changes in body size in Hispanic children with acute lymphoblastic leukemia. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Overweight in childhood cancer patients at diagnosis and throughout therapy: A multicentre cohort study. [2020]

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

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. [2022]

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

The effect of oral nutrition supplements and appetite stimulants on weight status among pediatric cancer patients: A systematic review. [2023]

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

Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. [2022]

10. Turkey pubmed.ncbi.nlm.nih.gov

The effect of an aerobic exercise program on the quality of life in children with cancer. [2019]