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Physical Activity in Pediatric Cancer (PAPEC)

Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01645436
Acronym
PAPEC
Enrollment
49
Registered
2012-07-20
Start date
2012-09-30
Completion date
2015-09-30
Last updated
2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

Keywords

randomized controlled trial, in-hospital exercise, children, cancer

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.

Detailed description

Sixty patients, of both sexes, children will be recruited for this trial with an age range between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to either intervention or control (usual care) group. 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. Primary outcomes \[cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry) and quality of life Child Report Form of the Child's Health and Illness Profile-Child Edition, Adolescent Edition and Parents Report Form )\] and secondary outcomes \[immune function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory profile (blood levels of 47 cytokines) and leukocyte telomere length\] will be measured in both groups in the following time points: (i) before the exercise intervention (immediately after diagnosis and before the start of treatment); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and iii) after a detraining period (2 months after the intervention).

Interventions

OTHERexercise training

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.

Sponsors

Universidad Europea de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* 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. -

Exclusion criteria

* age\<4 years or \>16 years, other tumours

Design outcomes

Primary

MeasureTime frame
Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise testsup to 3 years

Secondary

MeasureTime frameDescription
inflammatory profileup to 3 yearsblood levels of 47 cytokines (including, among others, interferon (IFN) α2, IFNγ, interleukin (IL)1α, IL1ß, IL1ra, IL2, IL2RA, IL3, IL4, IL6, IL7, IL8, IL9, IL10, IL12, IL13, IL15, IL16, IL17, tumor necrosis factor(TNF)-related apoptosis-inducing ligand, and TNFα.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026