Pediatric CancerNCT05058508
LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients
A study testing "Just Move" Exercise in people with Pediatric Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- "Just Move" Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 2-25 at time of consent
- Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles
- Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
- As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study
- Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment.
- Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic.
- Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment.
- Not participating in another clinical trial that precludes participating in additional nondrug clinical trials.
Who cannot join
- Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
- Any other uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements or would be considered unsafe for the child to participate as determined by the Investigator.
- Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
- Primary CNS Tumor
- Osteosarcoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Children's Hospital
Charlotte, North Carolina, 28203
Meg Lattanze, 980-442-4239, Megan.Lattanze@advocatehealth.org
Jennifer Pope, MD
About this study
Official title: LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
Read the detailed description
This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.
- Conditions
- Pediatric Cancer
- Being tested
- "Just Move" Exercise, Standard of Care Exercise
- Keywords
- Exercise, Pediatric Oncology
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Just Move" ExerciseOther
Subjects complete "Just Move" Exercises Five Times Per Week
Standard of Care ExerciseOther
Subjects exercise/move as tolerated
| Study group | Role | What they receive |
|---|---|---|
| EXER | Experimental | "Just Move" exercises Receives: Other: "Just Move" Exercise |
| SOC EXER | Experimental | Standard of Care Exercise Receives: Other: Standard of Care Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test
Measured: 18 month period
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by BOT-2 Brief (in subjects ≥ 4 years of age) or PDMS-2 (in subjects < 4 years of age).
Measured: 18 month period
Secondary outcomes (4)
Adverse Event Rate
Occurrence of Adverse Events of Special Interest (thromboembolic event, skin ulceration, significant nausea/vomiting, and constipation) will be measured as binary variables.
Measured: up to 18 months
Quality of Life measured by the PedsQL Cancer Module
Investigate if a structured exercise regimen relative to the control arm will result in Increasing and /or maintaining quality of life as measured by the PedsQL Cancer Module. Peds QL scores will be calculated as a composite quantitative analogue variable ranging from zero (best score) to 100 (worst score).
Measured: up to 18 months
Subject adherence to exercise regimen
Subject adherence to exercise regimen will be determined by patient-reported tracker listing activity performed and duration of time of activity. Data collected will be normalized quantitatively based on intended activity.
Measured: up to 18 months
Adverse Events Related to Exercise Program
To summarize adverse event rates deemed to be related to the protocol directed exercise program. Adverse events of special interest (Grade 2 or greater Bone fracture, Fall, and Muscle aches/Myalgia) will be captured for each subject and time point randomized to the intervention arm.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start11 Mar 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer Pope, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058508
- Sponsor's protocol ID
- IRB00082746
- Other IDs
- LCI-PED-NOS-EXER-001
- Status last verified
- Jul 2026
- First submitted
- 14 Sep 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT05058508
- Acronym / sponsor ID
- IRB00082746
- Conditions
- Pediatric Cancer
- Keywords
- Exercise, Pediatric Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Sep 2021 (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.
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
Detailed description
This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXER | Experimental | Other: "Just Move" Exercise"Just Move" exercises |
| SOC EXER | Experimental | Other: Standard of Care ExerciseStandard of Care Exercise |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Ages 2-25 at time of consent
- Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles
- Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
- As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study
- Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment.
Key exclusion criteria (5 listed)
- Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
- Any other uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements or would be considered unsafe for the child to participate as determined by the Investigator.
- Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
- Primary CNS Tumor
- Osteosarcoma
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 |
|---|---|---|
| "Just Move" ExerciseSubjects complete "Just Move" Exercises Five Times Per Week | Other | EXER |
| Standard of Care ExerciseSubjects exercise/move as tolerated | Other | SOC EXER |
Primary outcome
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Time frame: 18 month period
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Time frame: 18 month period
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by BOT-2 Brief (in subjects ≥ 4 years of age) or PDMS-2 (in subjects < 4 years of age).
4 secondary outcomes
Adverse Event Rate
Time frame: up to 18 months
Quality of Life measured by the PedsQL Cancer Module
Time frame: up to 18 months
Subject adherence to exercise regimen
Time frame: up to 18 months
Adverse Events Related to Exercise Program
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Pope, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Just Move" Exercise in people with Pediatric Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meg Lattanze ((980) 442-4239, Megan.Lattanze@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment (time frame: 18 month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.