NCT05188755

Brief Summary

Regular physical activity (PA) is associated with maintaining body composition, increased cardiorespiratory capacity, muscle mass and bone mineral density. In the event of a cancer, the development of physical capacities and metabolism may therefore be disturbed by cancer, these associated treatments (chemotherapy, radiotherapy and hematopoietic stem cell transplantation) but also undernutrition and the reduction in physical activity or even a sedentary lifestyle. Although the benefits of PA in oncology are now well identified for adult populations, studies are still rare in the population of children, adolescents and young adults, and the results are still difficult to generalize. As a result, there is no recommendation on the practice of physical activity in pediatric oncology or adolescents and young adults and the levels of physical activity of cured patients remain lower than those of the general population. Fitness is a marker of health in adults as well as in adolescents. Physical condition is a set of components such as cardiorespiratory capacity (transport and use of O2), body composition (distribution of bone, muscle and fat masses) and muscle function (strength, power, fatigue, energy metabolism) . The investigators hypothesize that, compared to young adults, recovered from lymphoma are expected to exhibit impaired physical condition, due to physical deconditioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

December 23, 2022

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

November 29, 2021

Last Update Submit

December 22, 2022

Conditions

Keywords

physical fitnessfat oxidationmetabolismexercise

Outcome Measures

Primary Outcomes (1)

  • fat oxidation rate

    maximum rate of lipid oxidation (in mg/ml)

    day at 11:30 am during one day

Secondary Outcomes (14)

  • rest metabolism

    at 08:00 am in fasted condition during one day

  • blood insulinemia

    at 07:30 am in fasted condition during one day

  • blood N-terminal pro-B natriuretic peptide

    at 07:30 am in fasted condition during one day

  • blood troponin

    at 07:30 am in fasted condition during one day

  • blood lipids

    at 07:30 am in fasted condition during one day

  • +9 more secondary outcomes

Study Arms (2)

Healthy controls

ACTIVE COMPARATOR

sex and age matched healthy controls

Other: Indirect calorimetric test during submaximal exercise

young adults recovered from lymphoma or Hodgkin's disease

EXPERIMENTAL

young adults recovered from lymphoma or Hodgkin's disease

Other: Indirect calorimetric test during submaximal exercise

Interventions

* metabolic evaluation by indirect calorimetry at rest and during exercise * evaluation of cardiac output * peripheral quantitative computed tomography (pQCT) of the muscle cross section * evaluation of body composition * assessment of physical capacity (chair test and 3 min step-test) * blood test * assess the level of physical activity

Also known as: cardiac output, body composition, assessment of physical capacity, blood test, accelerometry, peripheral quantitative computed tomography
Healthy controlsyoung adults recovered from lymphoma or Hodgkin's disease

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young adult male or female, aged 18 to 25
  • giving free and informed consent
  • Hodgkin lymphoma or non-Hodgkin lymphoma in the healing stage
  • Cured (defined by an undetectable disease at the end of treatment) for at least one year and maximum 6 years of lymphoma or Hodgkin's disease

You may not qualify if:

  • Legal incapable adults
  • People under judicial protection
  • Treatment with systemic glucocorticoids for more than a week, during the 30 days preceding the tests
  • Medical contraindication to the practice of physical exercise
  • Any pathologies (other than the history of lymphoma for the cases) likely to affect the metabolism or the muscle mass
  • Any treatment that may have an influence on the energy metabolism
  • Active infection
  • Pregnant, breastfeeding, or likely to be
  • Subject's refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseMotor Activity

Interventions

Cardiac OutputBody CompositionHematologic TestsAccelerometry

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaBiochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionPhysiological PhenomenaClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • Justina Kanold

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

January 12, 2022

Study Start

January 1, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Last Updated

December 23, 2022

Record last verified: 2021-11

Locations