Lymphoma Clinical Trial
— HBHLOfficial title:
Healthy Bones, Healthy Life: Effect of Habitual Physical Activity on Bone and Metabolic Health in Pediatric Cancer Survivors
Verified date | December 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | May 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Children between the ages of 5-18 2. Diagnosis of ALL or Lymphoma 3. Between 1-13 months post-cancer treatment Exclusion Criteria: 1. Children younger than 5 years old or 19 or older 2. Children without a diagnosis of ALL or lymphoma 3. Children receiving ongoing cancer treatment 4. Children with Down syndrome (identified as a precancerous condition affecting BMD) 5. Children with a prior history of bisphosphonate use or other medication directed at increasing bone density |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Mineral Density (g/cm2) | z-score of lumbar Spine bone density- DXA scan | 6 months | |
Primary | Hip structural analysis | DXA scan | 6 months | |
Primary | Physical Activity Level | Physical Activity as measured by accelerometry | 6 months | |
Secondary | 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 | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Hemoglobin A1c | measure of the glycated hemoglobin in blood, which is an indicator of insulin sensitivity | 6 months | |
Secondary | Vitamin D | measures the levels of vitamin D in the blood which is an indicator of bone health | 6 months |
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