Physical Activity in Pediatric Cancer (PAPEC)
PAPEC
1 other identifier
interventional
49
1 country
1
Brief Summary
The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer patients undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention will have a beneficial effect on the study outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 1, 2016
May 1, 2016
3 years
July 15, 2012
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests
up to 3 years
Secondary Outcomes (1)
inflammatory profile
up to 3 years
Study Arms (2)
treatment (exercise)
EXPERIMENTALcombined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
control (usual care)
NO INTERVENTIONUsual hospital care with no exercise
Interventions
The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Eligibility Criteria
You may qualify if:
- age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors) treated in the Hospital Infantul Niño jesús and residents in Madrid community. -
You may not qualify if:
- age\<4 years or \>16 years, other tumours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009, Spain
Related Publications (1)
Soares-Miranda L, Fiuza-Luces C, Lassaletta A, Santana-Sosa E, Padilla JR, Fernandez-Casanova L, Lorenzo-Gonzalez R, Lopez-Mojares LM, Perez M, Perez-Martinez A, Lucia A. Physical Activity in Pediatric Cancer patients with solid tumors (PAPEC): trial rationale and design. Contemp Clin Trials. 2013 Sep;36(1):106-15. doi: 10.1016/j.cct.2013.05.012. Epub 2013 Jun 5.
PMID: 23747802DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro Lucia, MD PhD
Universidad Europea de Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD, PROFESSOR IN EXERCISE PHYSIOLOGY
Study Record Dates
First Submitted
July 15, 2012
First Posted
July 20, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 1, 2016
Record last verified: 2016-05