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Clinical Trials/NCT01645436
NCT01645436
Completed
Not Applicable

Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Universidad Europea de Madrid1 site in 1 country49 target enrollmentStarted: September 2012Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Universidad Europea de Madrid
Enrollment
49
Locations
1
Primary Endpoint
Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 16 Years (Child)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests

Time Frame: up to 3 years

Secondary Outcomes

  • inflammatory profile(up to 3 years)

Investigators

Sponsor
Universidad Europea de Madrid
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alejandro Lucia

MD PhD, PROFESSOR IN EXERCISE PHYSIOLOGY

Universidad Europea de Madrid

Study Sites (1)

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