Clinical trial NCT01666015: Exercise in Pediatric Autologous Stem Cell Transplant Patients
Official title: Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Autologous Hematopoietic Stem Cell Transplantation
Keywords: pediatric
exercise
hematopoietic stem cell transplantation
cancer
quality of life
immune system
physical activity levels
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
First posted: 2012-08-16
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Hematological and Immunological Recovery
timeFrame: This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
Other outcomes:
measure: Health-related fitness assessment
timeFrame: Assessment will be completed at baseline, 30 and 90 days after SCT
measure: Physical activity levels
timeFrame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
measure: Demographic and health assessment
timeFrame: This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT
measure: Dietary intake
timeFrame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre
name: Nicole S Culos-Reed, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Kinesiology, University of Calgary.
name: Carolina Chamorro-Viña, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamorro-Vina C, Guilcher GM, Khan FM, Mazil K, Schulte F, Wurz A, Williamson T, Reimer RA, Culos-Reed SN. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol. BMC Cancer. 2012 Sep 10;12:401. doi: 10.1186/1471-2407-12-401.