ChildrenNCT00839904
Physical Activity and Health of Children With Cancer in Remission
A study testing exercise in people with Children and Cancer, run by Hadassah Medical Organization.
Trial summary
Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2012
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-16
- remission from cancer
- >6 months after completion of all therapy
Who cannot join
- informed consent not given in writing
- refusal of tests: blood, fitness, questionnaires or DEXA
- locomotive handicaps
- extreme fatigue, nausea, dyspnea
- concurrent acute illness
- recent (less than 3 months) hospitalization
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- documented (echocardiographic or nuclear medicine) decrease in cardiac function
- abnormal blood tests: Hb < 10 gr/dl, neutropenia < 500/mm3, thrombocytopenia < 50,000/mm3
- additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)
About this study
Official title: The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.
- Being tested
- exercise
- Keywords
- children, cancer, exercise, fitness, body composition
- 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.
exerciseBehavioural
two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day Receives: Behavioral: exercise |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related quality of life
Measured: 6months
mood
Measured: 6months
cardiorespiratory fitness
Measured: 6months
body fat percentage
Measured: 6months
bone mineral density
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Cancer Association
- Responsible party
- Principal investigator, gal dubnov raz, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839904
- Sponsor's protocol ID
- GDR2-HMO-CTIL
- Status last verified
- Jul 2013
- First submitted
- 8 Feb 2009
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
- ClinicalTrials.gov ID
- NCT00839904
- Acronym / sponsor ID
- GDR2-HMO-CTIL
- Keywords
- children, cancer, exercise, fitness, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Israel Cancer Association
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Feb 2009 (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.
Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: exercisetwo supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 6-16
- remission from cancer
- >6 months after completion of all therapy
Key exclusion criteria (9 listed)
- informed consent not given in writing
- refusal of tests: blood, fitness, questionnaires or DEXA
- locomotive handicaps
- extreme fatigue, nausea, dyspnea
- concurrent acute illness
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 |
|---|---|---|
| exercisetwo supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day | Behavioural | exercise |
Primary outcome
health-related quality of life
Time frame: 6months
mood
Time frame: 6months
cardiorespiratory fitness
Time frame: 6months
body fat percentage
Time frame: 6months
bone mineral density
Time frame: 6months
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 30 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Children and Cancer, run by Hadassah Medical Organization.
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 3 inclusion and 9 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
health-related quality of life (time frame: 6months). The study lists 5 primary outcomes in all. 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 30 Jul 2013.