Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07634653
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exercises — BEHAVIORAL
    Participants will follow a strength-training routine using rubber resistance bands and their own body weight, completing exercises at least three times per week and recording the time spent on their study form. They will receive ongoing support through optional Zoom or phone check-ins, with the choice to join group online sessions or complete supervised sessions individually. The intervention begins Day 8 and continues through Consolidation Day 29.

Study Details

Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile. Treatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms. Effective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home. This study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)
    Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.
  • No Intervention: Caregivers of Children with Acute lymphoblastic lymphoma or Acute lymphoblastic leukemia (ALL)
    Caregivers of Children diagnosed with Acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma who are medically able to exercise will be eligible to join the exercise program.

Primary Outcome Measure

Proportion of subjects completed exercise intervention [ Time Frame: Up to 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Juanita Cuffee
[email protected]
919-966-0017
Jessica Buddenbaum, MS
[email protected]
Thomas Alexander, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center· Chapel Hill, NC

Related Studies