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

Lymphoma Clinical Trial

— HBHL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04472286
• Other study ID #: 0206-20-FB
• Status: Active, not recruiting
• Start date: November 1, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Bone Loss
• Habitual Physical Activity
• Leukemia
• Leukemia, Lymphoid
• Lymphoid Leukemia
• Lymphoma
• Metabolic Syndrome
• Osteoporosis
• Osteoporosis Risk
• Pediatric
• Pediatric ALL
• Pediatric Lymphoma
• Precursor Cell Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

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