Physical Activity in Acute Lymphoblastic Leukemia (ALL) (ALL)

January 14, 2025 updated by: Shlomit Aizik, University of California, Irvine

Assessing Fitness, Physical Activity and Leukocyte Genomic Response to Exercise in Acute Lymphoblastic Leukemia (ALL) Patients in Remission

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute lymphocytic leukemia (ALL) is the most common hematological malignancy in children and adolescents. The gratifying and dramatic improvement in the survivorship of ALL is a testament to the strength of collaborative, multidisciplinary translational research efforts. Yet many gaps in our fundamental knowledge of disease mechanisms in ALL remain and hamper our ability to prolong remission and decrease disease relapse. There is increasing evidence that environmental, lifestyle factors such as physical exercise and fitness may play a beneficial role in cancer survivorship. The NCI has recently posted a Program Announcement to stimulate research on the impact of lifestyle interventions (e.g., exercise, nutrition) on cancer survivorship. The goal of this project is a development of a series of novel, hypothesis-driven proof of concept studies to explore ways in which exercise might benefit survivorship in ALL. The purpose of this initial project and Institutional Review Board (IRB) application is to gather minimally invasive data about patterns of physical activity and exercise, and leukocyte genomic response to exercise in children treated for ALL. These data will be essential in developing a larger protocol in response to the National Cancer Institute Program Announcement (NCI PA), one that addresses the NCI challenge that, "The biobehavioral mechanisms and pathways through which lifestyle interventions may increase survival following cancer are unknown." In addition, a number of studies have demonstrated that cardiovascular risk factors (such as BMI) in ALL survivors deteriorate following therapy. Exercise training interventions can improve cardiovascular risk in these patients; however, are difficult to implement in this population.

Consequently, in preparation for a larger study of exercise training on leukocyte genomic and epigenetic responses in ALL survivors, an essential biobehavioral component of any training study will be tested, namely, readiness for exercise training using approaches developed by researchers in our group. This part of our research will help us identify and target the unique set of fears and obstacles that almost invariably accompany children and adolescents (and their caregivers) who survive life-threatening diseases.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy
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
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.
Experimental: Children Diagnosed with ALL
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene Expression Profile (RNAseq)
Time Frame: 8-12 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural Killer (NK) Activity (NKCA)
Time Frame: Baseline and immediately following acute exercise
NKCA before and after acute bout of exercise in ALL children and healthy controls. NKTEST® kit from Glycotope Biotechnology (Allele Biotechnology, San Diego, CA) was used to evaluate NKCA per the kit instructions. The NKTEST kit quantifies NKCA using green fluorescent. NKCA was reported as the percentage of red-stained cells over total green-stained cells.
Baseline and immediately following acute exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Shlomit Radom-Aizik, Ph.D., University of California, Irvine Pediatric Exercise and Genomics Research Center (PERC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2003

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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