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Initiation of Adapted Physical Activity for Patients With Advanced Pediatric Malignancies

NCT03659968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-02-11

No results posted yet for this study

Summary

Adapted physical activity (APA) in the context of cancer is a field of growing interest and has been explored in numerous publications. In adults, the effects of APA on survival, symptoms and quality of life are established and its physiological consequences on immunity, angiogenesis and hormone secretion are under investigation.

In children and adolescents, evidence is scarce: pilot studies show clinical benefit of physical activity practiced in a wide variety of situations and protocols with low level of scientific evidence. It is therefore not possible to recommend this practice in pediatrics despite the large number of initiatives and the conviction of many clinicians that there is a benefit for patients. In particular, there are few trials in children with advanced cancer pathologies or in palliative care. However, these patients have a high prevalence of severe symptoms (pain, digestive disorders, asthenia, and anxiety) for which physical activity may represent a therapeutic option.

The purpose of our study is to describe a protocol of adapted physical activity and to evaluate its feasibility and toxicity according to a well-known and validated methodology in oncology used in drug development.

Methodology is based on a simple and reproducible intervention combining brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients.

The primary objective is to define the volume of physical activity that can be proposed to a patient starting APA based on the assessment of his physical condition evaluated by a 6-minutes walking distance test.

Inclusion criteria are broad to allow study population to represent the diversity of patients in pediatric palliative oncology. Stratification of patients in three groups based on a 6-minutes walking distance test aims to adapt intervention to physical capability of patients and improve tolerance.

Dose escalation will be set with a "3 + 3" regimen used in drug early phases trials.

Primary outcome measure is perceived tolerance evaluated by the patient with a subjective scoring on CREST scale. Any score greater than 8/10 defines intolerance.

Conditions

  • Pediatric Cancer

Interventions

OTHER

Physical activity training

brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • EMILIE GARRIDO PRADALIE · APHM

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659968 on ClinicalTrials.gov