Childhood CancerONKOKIDS-HDNCT02216604
Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment
A study testing Multimodal Exercise Intervention in people with Childhood Cancer, run by German Cancer Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Multimodal Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
- date of diagnosis not longer than 8 weeks ago
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Children's Hospital of the University Hospital of Heidelberg
Heidelberg, 69120
About this study
Official title: Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy
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
- Conditions
- Childhood Cancer
- Being tested
- Multimodal Exercise Intervention
- Keywords
- Exercise, Pediatric oncology, Physical Performance, Quality of Life, Feasibility, during primary, anticancer treatment
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Exercise InterventionBehavioural
During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Multimodal Exercise intervention (console-based training, age-specific resistance training and body awareness) Receives: Behavioral: Multimodal Exercise Intervention |
| Control | No intervention | age, disease and gender matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility after 6 month
Will be measured as the proportion of patients following the exercise prescription.
Measured: after primary treatment (6 month)
Secondary outcomes (3)
Physical performance
Strength (handheld dynamometer), endurance and balance capacity (TUDS, one leg stand), postural control functional mobility (posturomed \& force plate), range of motion (goniometer)
Measured: after primary treatment (6 month) and after one year
Quality of Life
KINDL questionnaire
Measured: after primary treatment (6 month) and after one year
Feasibility between 6 and 12 month
Will be measured as the proportion of patients following the exercise prescription.
Measured: between end of primary treatment (6 month) and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Heidelberg University, University of Leipzig, Children's Medical Hospital, University of Leipzig, Leipzig, Germany
- Responsible party
- Sponsor
- Investigators
- Joachim Wiskemann, PhD, Principal investigator, National Center for Tumor Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216604
- Sponsor's protocol ID
- S105-2011
- Acronym
- ONKOKIDS-HD
- Status last verified
- Mar 2019
- First submitted
- 13 Aug 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention Program for Childhood Cancer Patients Under Chemo- and/or Radiation Therapy
- ClinicalTrials.gov ID
- NCT02216604
- Acronym / sponsor ID
- ONKOKIDS-HD / S105-2011
- Conditions
- Childhood Cancer
- Keywords
- Exercise, Pediatric oncology, Physical Performance, Quality of Life, Feasibility, during primary, anticancer treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Heidelberg University, University of Leipzig, Children's Medical Hospital, University of Leipzig, Leipzig, Germany
- Study start
- May 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multimodal Exercise InterventionMultimodal Exercise intervention (console-based training, age-specific resistance training and body awareness) |
| Control | No intervention | –age, disease and gender matched |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
- date of diagnosis not longer than 8 weeks ago
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Exercise InterventionDuring their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level. | Behavioural | Intervention group |
Primary outcome
Feasibility after 6 month
Time frame: after primary treatment (6 month)
Will be measured as the proportion of patients following the exercise prescription.
3 secondary outcomes
Physical performance
Time frame: after primary treatment (6 month) and after one year
Quality of Life
Time frame: after primary treatment (6 month) and after one year
Feasibility between 6 and 12 month
Time frame: between end of primary treatment (6 month) and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
Related trials for Childhood Cancer
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Wiskemann, PhD principal investigator
National Center for Tumor Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Exercise Intervention in people with Childhood Cancer, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility after 6 month (time frame: after primary treatment (6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.