Exercise in Pediatric Autologous Stem Cell Transplant Patients

Cancer Clinical Trial

— SCORE  

Official title:

Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01666015
• Other study ID #: RF-CACICPES01
• Secondary ID: University of Ca
• Status: Terminated
• Phase: N/A
• First received: August 10, 2012
• Last updated: October 24, 2016
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada:Alberta Children's Hospital Research Institute (ACHRI)
• Study type: Interventional

Clinical Trial Summary

Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle.

Methods

Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.

Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• autologous SCT at Alberta Children`s Hospital (ACH) for malignancy

• age 5 to 18 years of age

• will be receiving myeloablative conditioning regimen

• no evidence of cardiac or pulmonary failure associated with treatment (SF=28%, EF = 50%)

• no functional nor cognitive limitation that would prohibit performance of the home-based training

• approval by treating oncologist for participants

• a parent or legal guardian must sign the consent form and

• children should express verbal assent to participate.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Autologous Hematopoietic Stem Cell Transplantation
• Cancer

Intervention

Other:
• EXERCISE (EX)
This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge. The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games).
• Standard Care
This group will be under standard care without any EX intervention.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related fitness assessment	Body composition; musculoskeletal fitness (flexibility, muscular strength and endurance); functional mobility and cardiorespiratory fitness will be performed.; Body composition: weight, height, skinfold measure (biceps, triceps, subscapular and suprailiac).; Flexibility: sit and reach Muscular strength: A hand- held dynamometer will be used to assess grip strength and knee extension.; Muscular endurance: modified push up, partial curl-up and 30 seconds squat test.; Functional mobility: Time up and go test (3 meters) Cardiorespiratory fitness: Treadmill submaximal test. Height and tanner stage will be used to determine duration of each stage (2-3 minutes) and initial velocity of the protocol.	Assessment will be completed at baseline, 30 and 90 days after SCT	No
Other	Physical activity levels	A triaxial accelerometer (Actical - Phillips respironic) will be put on when the participant gets up from bed each day and worn until the participant is ready to fall asleep. Subjects can go about their normal, daily activities, including rigorous exercise, swimming or bathing. During each assessment subjects will be instructed to wear the activity monitor over their right hip on an elasticized belt for seven consecutive days. Additionally, participants will be asked to record, in a daily log, the time they put on and took off the monitor each day.	Assessment will be completed at baseline, 30, 90 and 180 days after SCT	No
Other	Demographic and health assessment	Demographic characteristics, health record information (type of cancer, disease status, co-morbid conditions, cancer treatment received, side-effects of treatment) and information related to SCT (platelet and neutrophil engraftment, conditioning regimen received, toxicities due to conditioning regimen, documented infection, incidence of fever) will be collected. A questionnaires will be filled out by the physician.	This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT	No
Other	Dietary intake	Usual dietary intake will be assessed using a 3-day dietary record. Dietary records will be analyzed by a Registered Dietitian using Diet Analysis Plus 10.0 software (Thomson Wadsworth, Toronto, Canada.	Assessment will be completed at baseline, 30, 90 and 180 days after SCT	No
Primary	Hematological and Immunological Recovery	Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.	This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)	No
Secondary	Quality of life (QOL)	Will be assessed using the Pediatric quality of life inventory (PedsQL) general and cancer module as a self-report, and PedsQL and Behavior Assessment System for Children (BASC-2) as parent proxy report. Fatigue will be assessed using the multidimensional PedsQL fatigue scale.	Assessment will be completed at baseline, 30, 90 and 180 days after SCT	No