Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Motor Proficiency And Physical Activity in Adult Survivors of Childhood ALL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047020
• Other study ID #: MTRPAL
• Secondary ID: R01CA132901
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: August 26, 2015
• Start date: June 2009
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary goal of this study is to provide comprehensive and objective information on impairments of musculoskeletal health, sensory function, and fitness among a large group of childhood ALL survivors, and to define high risk groups by assessing treatment factors that contribute to impaired function. This study includes a direct, objective evaluation of musculoskeletal function, sensory capacity, fitness, and physical activity patterns among adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH) between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an institutionally funded clinical study of medical late effects, the study will recruit 364 to participate in our evaluations. The study will also recruit 364 individuals for a comparison group, frequency matching on race/ethnicity, age and gender.

Description:

The study will focus on the following primary objectives:

1. Enumerate the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL will have a higher prevalence of musculoskeletal, sensory and fitness impairments than a control group frequency matched on race/ethnicity, age, and gender.

2. Evaluate the association between personal and treatment factors and musculoskeletal, sensory and fitness impairments. The study hypothesizes that:

• Female gender, younger age at diagnosis, and cranial radiation will be associated with decreased lean body mass.

• Female gender, younger age at diagnosis, and type of glucocorticoid (dexamethasone vs. prednisone) treatment will be associated with muscle weakness.

• Sensory loss will vary as a function of age, with participants diagnosed at 12+ years of age demonstrating vincristine related sensory loss, and those diagnosed at <12 years of age demonstrating dexamethasone and/or intrathecal methotrexate related sensory loss.

• Fitness impairments will be evident in participants who received 100 mg/m2+ of anthracyclines.

The study will focus on the secondary objectives:

1. Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group. The study hypothesizes that adult survivors of childhood ALL will demonstrate lower levels of physical activity as measured with an activity monitor (accelerometer), and will report lower levels of overall physical activity, when compared to members of the comparison group.

2. Describe the association between habitual physical activity and energy expenditure among ALL survivors. The study hypothesizes that activity levels, measured with the accelerometer, will be positively correlated with energy expenditure, measured using the doubly labeled water technique.

3. Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL. The study hypothesizes that adult survivors of childhood ALL with lower proportions of lean muscle mass and/or sensory loss indicating peripheral neuropathy will demonstrate the lowest levels of physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 807
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:(ALL survivors):

1. Research participant who is a survivor of childhood ALL who was treated at St. Jude Children's Research Hospital between 1980 and 1999

2. Research participant must be at least ten years from diagnosis

3. Research participant must be at least 18 years of age at the time of the scheduled evaluation

Exclusion Criteria (ALL survivors):

1. Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function

2. Research participant currently pregnant or lactating

3. Research participant age 17 years or less

4. Research participant undergoing active treatment for cancer

Inclusion Criteria (Comparison Group)

1. Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient.

2. Research participant must be at least 18 years of age at the time of the scheduled evaluation

Exclusion Criteria (Comparison Group)

1. Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function

2. Research participant currently pregnant or lactating

3. Research participant age 17 years or less

4. Research participant has a medical history of cancer

5. Research participant is a first degree relative of a survivor participating in MTRPAL

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI), University of Pittsburgh, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.		Day 1-2	No
Secondary	Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.		Day 1-7	No
Secondary	Describe the association between habitual physical activity and energy expenditure among ALL survivors.		Day 1-7	No
Secondary	Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL.		Day 1-7	No

External Links

•   St. Jude Children's Research Hospital