Fitness Assessment in Young Adults Recovered From Lymphoma
CUPCAKE
2 other identifiers
interventional
44
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2022
CompletedDecember 23, 2022
November 1, 2021
11 months
November 29, 2021
December 22, 2022
Conditions
Keywords
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 COMPARATORsex and age matched healthy controls
young adults recovered from lymphoma or Hodgkin's disease
EXPERIMENTALyoung adults recovered from lymphoma or Hodgkin's disease
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
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justina Kanold
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- 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