Initiation of Adapted Physical Activity for Patients With Advanced Pediatric Malignancies

NCT03659968 | Completed

• 1 other identifier: 2017-70
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Perceived tolerance

  Evaluated by the patient with a subjective scoring on scale (from 0 to 10). Any score greater than 8/10 define intolerance. Any score under 8/10 definite "acceptable tolerance"

  6 weeks

Study Arms (1)

EXPERIMENTAL GROUP

EXPERIMENTAL

patients in advanced phase of pediatric cancer Physical activity training will be performed in drug development

Other: Physical activity training

Interventions

Physical activity training OTHER

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

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged from 5 to 17 years old.
• Cancer with no curative therapeutic options.
• Stable disease (with or without treatment).
• Ability to complete 100 meters walking without help and muscular strengthening exercises.
• Written informed consent, including agreement of parents or legal guardian for minors.

You may not qualify if:

• Participation to another Phase I trial
• Dyspnoea exertional
• Cardio-vascular pathology
• Life expectancy of less than 3 months
• Progressive disease
• Expected inability to comply to medical follow up

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assiatnce Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: January 20, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

FR (1)