Clinical trial NCT02216604: Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment
Official title: Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Keywords: Exercise
Pediatric oncology
Physical Performance
Quality of Life
Feasibility
during primary
anticancer treatment
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: Heidelberg University
name: University of Leipzig
name: Children's Medical Hospital, University of Leipzig, Leipzig, Germany
First posted: 2014-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year


Eligibility criteria: Inclusion Criteria:

* pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
* date of diagnosis not longer than 8 weeks ago

Exclusion Criteria:

* severe cardiac impairment
* bone metastasis inducing skeletal fragility
* other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements.

Primary outcomes:
measure: Feasibility after 6 month
timeFrame: after primary treatment (6 month)
Secondary outcomes:
measure: Physical performance
timeFrame: after primary treatment (6 month) and after one year
measure: Quality of Life
timeFrame: after primary treatment (6 month) and after one year
measure: Feasibility between 6 and 12 month
timeFrame: between end of primary treatment (6 month) and one year
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Children's Hospital of the University Hospital of Heidelberg
Study officials:
affiliation: National Center for Tumor Diseases
name: Joachim Wiskemann, PhD
role: PRINCIPAL_INVESTIGATOR
References: