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Acute Lymphoblastic Leukemia, PediatricHBHLNCT04472286

Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors

An observational study of Acute Lymphoblastic Leukemia, Pediatric and Pediatric ALL, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. Read more about this study

Who is it for?
Ages 5 to 18 years
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 30 May 2024
Phase
Observational
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 5 to 18 years
  • All sexes
  • Child, Adult

Study population: Pediatric cancer survivors who are in the first year after treatment completion

Who may be able to join

  • Children between the ages of 5-18
  • Diagnosis of ALL or Lymphoma
  • Between 1-13 months post-cancer treatment

Who cannot join

  • Children younger than 5 years old or 19 or older
  • Children without a diagnosis of ALL or lymphoma
  • Children receiving ongoing cancer treatment
  • Children with Down syndrome (identified as a precancerous condition affecting BMD)
  • Children with a prior history of bisphosphonate use or other medication directed at increasing bone density

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Healthy Bones, Healthy Life: Effect of Habitual Physical Activity on Bone and Metabolic Health in Pediatric Cancer Survivors

This project will examine habitual physical activity, bone health, and insulin resistance in pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points: baseline and 6 months. At the two study timepoints, all study participants will be asked to wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn for analysis. Study participants will be given a gift card stipend for each study visit attended. Study visits will coincide with regular office visits to Children's Hospital Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The potential mechanism by which physical activity mediates bone changes will be explored by concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will provide data to inform the design of a randomized controlled trial to test the effect of a physical activity intervention on bone health in PCS.

Read the detailed description

Childhood cancer treatments are increasingly effective, leading to dramatic improvements in survival rates. These treatments often have devastating effects on the overall health of pediatric cancer survivors (PCS) since they occur during a critical time of bone growth, including increased risks of poor bone health, fracture, and diabetes. In normal child development, physical activity habits influence bone density and structure, which affect bone strength in adulthood. Despite this well-understood principle of bone development, there are no exercise guidelines for improving bone health in PCS. The long-term goal of this research is to develop an effective exercise intervention to improve bone health after cancer therapy. As a first step, the investigators propose to test the hypothesis that the intensity and amount of ground impact of a child's daily physical activity will influence changes in bone density in PCS. The Specific Aims are to (1) examine the effect of physical activity on lumbar bone density of PCS and to (2) evaluate how physical activity influences bone density. In a prospective cohort study, the investigators will enroll 38 pediatric and adolescent survivors (ages 5-18) of acute lymphoblastic leukemia or lymphoma at any post-treatment time point. Aim 1: At two assessments, baseline and six months later, bone density and structure (by DXA scan, a type of x-ray that can measure bone density and the amount of muscle and fat in the body) and physical activity level (by accelerometry, a device like a fitness tracker) will be evaluated. Each child will be categorized as having low or high physical activity based on accelerometry measures averaged from baseline and six-month assessments. Bone changes (0-6 months) will be compared between low and high activity groups. Aim 2: Evaluate potential mechanisms by which physical activity mediates changes in bone, including the effects of lean mass (measured by DXA) and metabolic health (lipid panel, insulin sensitivity (HOMA-IR, hemoglobin A1c), vitamin D). Long-term impact: This research will provide information as to the types of exercise that impact bone health in PCS. This study will help develop effective, evidence-based exercise therapies. These therapies may help prevent fractures and associated disability, leading to an improvement in the quality of life for survivors of pediatric cancer.

Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Bone Diseases, Metabolic, Metabolic Syndrome, Lymphoma, Leukemia, Leukemia, Lymphoid, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04472286
Study groupRoleWhat they receive
Pediatric Cancer SurvivorsChildren and adolescents who have completed treatment of for acute lymphoblastic leukemia (ALL) and lymphoma.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Mineral Density (g/cm2)

    z-score of lumbar Spine bone density- DXA scan

    Measured: 6 months

  2. Hip structural analysis

    DXA scan

    Measured: 6 months

  3. Physical Activity Level

    Physical Activity as measured by accelerometry

    Measured: 6 months

Secondary outcomes (4)
  1. Lipid panel

    cholesterol (total, HDL, and LDL) and triglycerides will be measured, which are an indicator of overall cardiovascular health which can impact insulin sensitivity

    Measured: 6 months

  2. Homeostatic Model Assessment for Insulin Resistance

    Fasting Insulin and Fasting Glucose will be combined to calculate the HOMA-IR, which is an indicator of insulin sensitivity

    Measured: 6 months

  3. Hemoglobin A1c

    measure of the glycated hemoglobin in blood, which is an indicator of insulin sensitivity

    Measured: 6 months

  4. Vitamin D

    measures the levels of vitamin D in the blood which is an indicator of bone health

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2020
  2. Study start1 Nov 2020
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04472286
Sponsor's protocol ID
0206-20-FB
Acronym
HBHL
Status last verified
Aug 2024
First submitted
10 Jul 2020
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Lymphoblastic Leukemia, Pediatric and Pediatric ALL, run by University of Nebraska 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 3 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: finished, as of the sponsor's last update on 30 Aug 2024. 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?

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?

Bone Mineral Density (g/cm2) (time frame: 6 months). The study lists 3 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 30 Aug 2024.

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