CUPCAKE: Fitness Assessment in Young Adults Recovered From Lymphoma

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188755
Collaborator
(none)
44
1
2
35.2
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Indirect calorimetric test during submaximal exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's diseasegroup 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Fitness Assessment in Young Adults Recovered From Lymphoma or Hodgkin's Disease
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 6, 2023
Anticipated Study Completion Date :
Dec 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthy controls

sex and age matched healthy controls

Other: Indirect calorimetric test during submaximal exercise
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
Other Names:
  • cardiac output
  • body composition
  • assessment of physical capacity
  • blood test
  • accelerometry
  • peripheral quantitative computed tomography
  • Experimental: young adults recovered from lymphoma or Hodgkin's disease

    young adults recovered from lymphoma or Hodgkin's disease

    Other: Indirect calorimetric test during submaximal exercise
    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
    Other Names:
  • cardiac output
  • body composition
  • assessment of physical capacity
  • blood test
  • accelerometry
  • peripheral quantitative computed tomography
  • Outcome Measures

    Primary Outcome Measures

    1. fat oxidation rate [day at 11:30 am during one day]

      maximum rate of lipid oxidation (in mg/ml)

    Secondary Outcome Measures

    1. rest metabolism [at 08:00 am in fasted condition during one day]

      energy expenditure at rest in kcal.

    2. blood insulinemia [at 07:30 am in fasted condition during one day]

      blood value of insulin in pmol/L

    3. blood N-terminal pro-B natriuretic peptide [at 07:30 am in fasted condition during one day]

      blood N-terminal pro-B natriuretic peptide level in g/L

    4. blood troponin [at 07:30 am in fasted condition during one day]

      blood troponin level in g/L

    5. blood lipids [at 07:30 am in fasted condition during one day]

      blood lipids level in g/L

    6. blood glucose [at 07:30 am in fasted condition during one day]

      blood glucose level in g/L

    7. Body composition: fat [at 07:30 am during one day]

      percentage of fat

    8. Body composition: lean mass [at 07:30 am during one day]

      percentage of lean mass

    9. cardiac output [at 11:30 am during one day]

      Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise

    10. peripheral quantitative computed tomography [at 10:45 am during one day]

      Cross-sectional area of thigh muscles and intermuscular adipose tissue were assessed for muscle at 40% of the length between the greater trochanter and the mid-patella of the right leg

    11. physical condition [at 08:45 am during one day]

      3 min step-test (number of ascent / descent step)

    12. physical capacity [at 08:45 am during one day]

      chair test (time in second held in position)

    13. physical activity level [from day 2 to day 5]

      daily energy expenditure (in Kcal)

    14. sedentary level [from day 2 to day 5]

      total sedentary time (in min) evaluated by accelerometer for 4 days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Clermont-Ferrand Clermont-Ferrand France 63000

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    • Principal Investigator: Justina Kanold, University Hospital, Clermont-Ferrand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT05188755
    Other Study ID Numbers:
    • RBHP 2021 KANOLD
    • 2021-A02184-37
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Clermont-Ferrand
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2022