Physical Activity in Pediatric Cancer (PAPEC)

Pediatric Cancer Clinical Trial

— PAPEC  

Official title:

Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645436
• Other study ID #: LUCIA
• Status: Completed
• Phase: N/A
• First received: July 15, 2012
• Last updated: May 31, 2016
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• exercise 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.

Locations

Country	Name	City	State
Spain	Hospital Infantil Universitario Niño Jesús	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests		up to 3 years	No
Secondary	inflammatory profile	blood levels of 47 cytokines (including, among others, interferon (IFN) a2, IFN?, interleukin (IL)1a, 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 TNFa.	up to 3 years	No