Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Physical Activity in Pediatric Cancer (PAPEC)

Sponsors

Lead sponsor: Universidad Europea de Madrid

Source Universidad Europea de Madrid
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).

Overall Status Completed
Start Date September 2012
Completion Date September 2015
Primary Completion Date September 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests up to 3 years
Secondary Outcome
Measure Time Frame
inflammatory profile up to 3 years
Enrollment 49
Condition
Intervention

Intervention type: Other

Intervention name: exercise training

Description: 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.

Arm group label: treatment (exercise)

Other name: physical activity

Eligibility

Criteria:

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

Gender: All

Minimum age: 4 Years

Maximum age: 16 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Alejandro Lucia, MD PhD Principal Investigator Universidad Europea de Madrid
Location
facility
Hospital Infantil Universitario Niño Jesús
Location Countries

Spain

Verification Date

May 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universidad Europea de Madrid

Investigator full name: Alejandro Lucia

Investigator title: MD PhD, PROFESSOR IN EXERCISE PHYSIOLOGY

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: treatment (exercise)

Arm group type: Experimental

Description: 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.

Arm group label: control (usual care)

Arm group type: No Intervention

Description: Usual hospital care with no exercise

Acronym PAPEC
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov