Acute LeukemiaALLNCT06783738
Physical Activity in Acute Lymphoblastic Leukemia (ALL)
A study testing Exercise in people with Acute Leukemia, run by University of California, Irvine.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2003to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Leukemia
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-12 minutes
Secondary outcomes (1)
Natural Killer (NK) Activity (NKCA)
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.
Measured: Baseline and immediately following acute exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start31 Jan 2003
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shlomit Aizik, University of California, Irvine
- Investigators
- Shlomit Radom-Aizik, Ph.D., Principal investigator, University of California, Irvine Pediatric Exercise and Genomics Research Center (PERC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783738
- Sponsor's protocol ID
- 1519
- Acronym
- ALL
- Status last verified
- Jan 2025
- First submitted
- 3 May 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20860019Jarvela 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.
PubMed 20552291Hartman 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.
PubMed 22745035Jarvela 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.
PubMed 22184098Hartman 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.
PubMed 19283791
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fitness, Physical Activity and Leukocyte Genomic Response to Exercise in Acute Lymphoblastic Leukemia (ALL) Patients in Remission
- ClinicalTrials.gov ID
- NCT06783738
- Acronym / sponsor ID
- ALL / 1519
- Conditions
- Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 31 Jan 2003 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Other: ExerciseAerobic 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. |
| Children Diagnosed with ALL | Experimental | Other: ExerciseAerobic 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Children Diagnosed with ALL, Healthy |
Primary outcome
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.
1 secondary outcome
Natural Killer (NK) Activity (NKCA)
Time frame: Baseline and immediately following acute exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 20860019Esbenshade 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.
- Background: PubMed 20552291Jarvela 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.
- Background: PubMed 22745035Hartman 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.
- Background: PubMed 22184098Jarvela 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.
- Background: PubMed 19283791Hartman 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.
- Individual participant dataSharing planned: No
Related trials for Acute Leukemia
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Radom-Aizik, Ph.D. principal investigator
University of California, Irvine Pediatric Exercise and Genomics Research Center (PERC)
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Acute Leukemia, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Profile (RNAseq) (time frame: 8-12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783738, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.