Physical Activity in Acute Lymphoblastic Leukemia (ALL)

NCT06783738 | Completed

• 1 other identifier: 1519
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute lymphoblastic leukemia (ALL) is the most common blood cancer of children and adolescents. Remarkable progress has been made in treating this deadly disease, but many children suffer relapses despite these advances. There are mounting data showing that lifestyle factors, specifically levels of exercise and nutritional intake, can have measurable and substantial impact on how well patients with a variety of cancers respond to treatment. It is not surprising that children and adolescents who have survived ALL tend to exercise less and be less fit than otherwise healthy subjects. But very little is known in pediatric patients with ALL about how exercise might be beneficial and prolong disease-free intervals. Recently, the National Cancer Institute (NCI) put out a call for research proposals designed to test mechanisms through which lifestyle interventions like exercise might prolong survivorship in cancer patients. The NCI specifically stressed the need to better understand the biological mechanisms through which behaviors like exercise could benefit cancer patients. Exciting work in our laboratory (HS# 2002-2598) demonstrates the substantial effect that exercise has on white blood cell gene expression. Our data actually suggest heretofore undiscovered mechanisms that might explain why exercise might be beneficial for children and teenagers treated with ALL. Under under HS#2012-9248, 8 pediatric ALL patients and 7 healthy controls, will be tested (for an overall sample size of 15) with, cardiopulmonary exercise testing used routinely to measure fitness in children. These data will provide us with essential information about fitness, and the immune system response to exercise in these patients and will be used to develop a broader set of studies and exercise interventions that, hopefully, will identify the ways in which exercise can serve as an adjunct to standard therapy for children with ALL.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Gene Expression Profile (RNAseq)

  Gene expression profile before and after acute exercise in children with acute lymphoblastic leukemia in remission compared to healthy control. Differential gene expression analysis was performed using DESeq2 (v.1.38.3). Paired design was used to account for samples from the same patient. Multifactor design with interaction terms was applied for group differences.

  8-12 minutes

Secondary Outcomes (1)

• Natural Killer (NK) Activity (NKCA)

  Baseline and immediately following acute exercise

Study Arms (2)

Healthy

ACTIVE COMPARATOR

Aerobic fitness will be assessed using incremental cycle-ergometer exercise test to determine peak maximum rate of oxygen use (VO2) in healthy subjects. Exercise testing will be performed at the University of California Irvine (UCI) Pediatric Exercise and Genomics Research Center (PERC)/Institute for Clinical and Translational Science (ICTS) Applied Physiology/Human Performance Core Laboratory. The work rate will increase by 5-10 W per min (or adjusted according to the subject's age and fitness level) so that the total exercise time will roughly equal 8-12 min, and each subject will exercise to the limit of his or her tolerance.

Other: Exercise

Children Diagnosed with ALL

EXPERIMENTAL

Aerobic fitness will be assessed using incremental cycle-ergometer exercise test to determine peak maximum rate of oxygen use (VO2) in ALL patients. Exercise testing will be performed at the University of California Irvine (UCI) Pediatric Exercise and Genomics Research Center (PERC)/Institute for Clinical and Translational Science (ICTS) Applied Physiology/Human Performance Core Laboratory. The work rate will increase by 5-10 W per min (or adjusted according to the subject's age and fitness level) so that the total exercise time will roughly equal 8-12 min, and each subject will exercise to the limit of his or her tolerance.

Other: Exercise

Interventions

Exercise OTHER

The participants will come to our lab twice. In the first visit we will perform a fitness assessment, using a noninvasive, cardiopulmonary exercise testing used routinely to measure fitness in children.

Children Diagnosed with ALL; Healthy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 10-17 (males and females)
• Diagnosed with ALL in remission stage
• No evidence of disability that would impair participation in a vigorous physical activity challenge

You may not qualify if:

• Pregnancy or breastfeeding
• Use of illegal drugs or alcohol
• Other conditions that preclude exercise (such as neuromotor disease, heart disease, or any other condition that would prevent a child from participating in vigorous physical activity)

Sponsors & Collaborators

• University of California, Irvine: lead

Related Publications (5)

• Esbenshade AJ, Simmons JH, Koyama T, Koehler E, Whitlock JA, Friedman DL. Body mass index and blood pressure changes over the course of treatment of pediatric acute lymphoblastic leukemia. Pediatr Blood Cancer. 2011 Mar;56(3):372-8. doi: 10.1002/pbc.22782.

  PMID: 20860019 BACKGROUND

• Jarvela LS, Niinikoski H, Lahteenmaki PM, Heinonen OJ, Kapanen J, Arola M, Kemppainen J. Physical activity and fitness in adolescent and young adult long-term survivors of childhood acute lymphoblastic leukaemia. J Cancer Surviv. 2010 Dec;4(4):339-45. doi: 10.1007/s11764-010-0131-0. Epub 2010 Jun 15.

  PMID: 20552291 BACKGROUND

• Hartman A, Hop W, Takken T, Pieters R, van den Heuvel-Eibrink M. Motor performance and functional exercise capacity in survivors of pediatric acute lymphoblastic leukemia. Pediatr Blood Cancer. 2013 Mar;60(3):494-9. doi: 10.1002/pbc.24243. Epub 2012 Jun 28.

  PMID: 22745035 BACKGROUND

• Jarvela LS, Kemppainen J, Niinikoski H, Hannukainen JC, Lahteenmaki PM, Kapanen J, Arola M, Heinonen OJ. Effects of a home-based exercise program on metabolic risk factors and fitness in long-term survivors of childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Jul 15;59(1):155-60. doi: 10.1002/pbc.24049. Epub 2011 Dec 19.

  PMID: 22184098 BACKGROUND

• Hartman A, te Winkel ML, van Beek RD, de Muinck Keizer-Schrama SM, Kemper HC, Hop WC, van den Heuvel-Eibrink MM, Pieters R. A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 Jul;53(1):64-71. doi: 10.1002/pbc.21942.

  PMID: 19283791 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shlomit Radom-Aizik, Ph.D.

  University of California, Irvine Pediatric Exercise and Genomics Research Center (PERC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: January 20, 2025
• Study Start: January 31, 2003
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share