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Strength Training Exercise for Acute Lymphoblastic Leukemia

(STEP-ALL Trial)

JB
JC
Overseen ByJuanita Cuffee
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a structured strength training exercise program affects children newly diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. The researchers aim to determine if a 9-week exercise plan, combined with weekly symptom check-ins, is practical and beneficial during the first phase of chemotherapy, potentially improving physical function and overall wellbeing. The trial includes a mix of in-person and virtual sessions, allowing children to safely participate from home. Children newly diagnosed with ALL or lymphoblastic lymphoma who are medically able to exercise are encouraged to join. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their wellbeing during treatment.

What prior data suggests that this exercise program is safe for children with ALL or lymphoblastic lymphoma?

Research has shown that strength training can be safe for children with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. One study with a 12-week strength training program found no harmful effects. This program included high-intensity exercises that increased strength without causing any issues. Other research has also demonstrated that low- to moderate-intensity aerobic and strength exercises three times a week are safe. These findings suggest that the exercise plan for the trial is well-tolerated and offers a safe way to improve fitness during treatment.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Acute Lymphoblastic Leukemia (ALL), which typically involve chemotherapy and targeted drug therapies, strength training exercise offers a non-pharmacological approach that aims to improve the physical health and quality of life for children with ALL. This method is unique because it focuses on enhancing muscle strength and overall well-being through physical activity, which can be particularly empowering for young patients. Researchers are excited about this trial because they hope to find out if regular exercise can serve as a supportive therapy, potentially reducing treatment side effects and improving recovery outcomes, thus offering a complementary approach to traditional medical treatments.

What evidence suggests that strength training exercise is effective for children with acute lymphoblastic leukemia?

Research has shown that strength training can benefit children with acute lymphoblastic leukemia (ALL). Studies indicate that exercise enhances muscle strength, movement, and overall fitness in these children. This is crucial because their treatment often weakens muscles and reduces fitness. Other research suggests that exercise can also improve quality of life and help manage long-term side effects such as weight gain and heart problems. Additionally, regular exercise may boost mood and reduce fatigue. This trial will evaluate a structured exercise program as a key component in managing ALL in children.13678

Who Is on the Research Team?

TA

Thomas Alexander, MD, MPH

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 6 to 21 who have just been diagnosed with B-cell or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Participants must provide consent (or assent with parental/guardian consent).

Inclusion Criteria

I was between 6 and 21 years old when I was diagnosed.
I am a child newly diagnosed with B-cell or T-cell leukemia or lymphoma.
I am a parent or legal guardian over 18 with a child under 18.
See 2 more

Exclusion Criteria

I am not taking any experimental or extra cancer medicines during induction.
Children: Significant concurrent disease, illness, psychiatric disorder, or social issue compromising safety, adherence, consent, participation, follow-up, or interpretation of study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive standard 3-4 drug induction chemotherapy

9 weeks
Combination of in-person and virtual sessions

Exercise Program

Participants engage in a 9-week hybrid exercise program with weekly symptom check-ins

9 weeks
24 sessions (3 per week), mix of in-person and virtual

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Strength Training Exercise

Trial Overview

The study is testing a supervised, hybrid strength training exercise program—combining in-person and virtual sessions—for kids newly diagnosed with ALL or lymphoblastic lymphoma during their first phase of chemotherapy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)Experimental Treatment1 Intervention
Group II: Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Citations

Physical training interventions for children and teenagers ...

A decreased physical fitness has been reported in patients and survivors of acute lymphoblastic leukemia (ALL). This is influenced by the ...

A supervised STreNgth & Outpatient Exercise Regimen in ...

As outcomes for children with acute lymphoblastic leukemia (ALL) improve, late effects such as metabolic syndrome and cardiovascular disease contribute to ...

Physical fitness throughout chemotherapy in children with ...

Quadriceps strength, functional mobility and endurance are decreased during treatment for acute lymphoblastic leukaemia/lymphoma. The lowest measurements are ...

Aerobic training versus strength exercises on muscle strength ...

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

Physical Activity to Modify Sequelae and Quality of Life in ...

View results for the PAQOL clinical trial, which studied physical activity in children with acute lymphoblastic leukemia and whether it improved quality of life ...

Study Details | NCT07634653 | Strength Training Exercise ...

Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include ...

Effects of a Combined Aerobic and Strength Training ...

No adverse effects occurred. A 12-week in-hospital training program including high-intensity resistance exercises promotes marked strength improvements in ...

Strength Training Exercise in Pediatric Acute Lymphoblastic ...

Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include ...