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Completed

NCT Number: NCT05188755

Fitness Assessment in Young Adults Recovered From Lymphoma

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indirect calorimetric test during submaximal exercise

Other
  • 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

Primary outcomes

  1. fat oxidation rate

    Time frame: day at 11:30 am during one day

    maximum rate of lipid oxidation (in mg/ml)

Secondary outcomes

  1. rest metabolism

    Time frame: at 08:00 am in fasted condition during one day

    energy expenditure at rest in kcal.

  2. blood insulinemia

    Time frame: 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

    Time frame: at 07:30 am in fasted condition during one day

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

  4. blood troponin

    Time frame: at 07:30 am in fasted condition during one day

    blood troponin level in g/L

  5. blood lipids

    Time frame: at 07:30 am in fasted condition during one day

    blood lipids level in g/L

  6. blood glucose

    Time frame: at 07:30 am in fasted condition during one day

    blood glucose level in g/L

  7. Body composition: fat

    Time frame: at 07:30 am during one day

    percentage of fat

  8. Body composition: lean mass

    Time frame: at 07:30 am during one day

    percentage of lean mass

  9. cardiac output

    Time frame: at 11:30 am during one day

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

  10. peripheral quantitative computed tomography

    Time frame: 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

    Time frame: at 08:45 am during one day

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

  12. physical capacity

    Time frame: at 08:45 am during one day

    chair test (time in second held in position)

  13. physical activity level

    Time frame: from day 2 to day 5

    daily energy expenditure (in Kcal)

  14. sedentary level

    Time frame: from day 2 to day 5

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Fitness Assessment in Young Adults Recovered From Lymphoma or Hodgkin's Disease

Acronym: CUPCAKE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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