Fitness Assessment in Young Adults Recovered From Lymphoma (CUPCAKE)

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Non-Hodgkin; Hodgkin Disease; Young Adults
• Intervention / Treatment: Other: Indirect calorimetric test during submaximal exercise

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: accelerometry; cardiac output; body composition; assessment of physical capacity; blood test; peripheral quantitative computed tomography
Experimental: 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: accelerometry; cardiac output; body composition; assessment of physical capacity; blood test; peripheral quantitative computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fat oxidation rate	maximum rate of lipid oxidation (in mg/ml)	day at 11:30 am during one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rest metabolism	energy expenditure at rest in kcal.	at 08:00 am in fasted condition during one day
blood insulinemia	blood value of insulin in pmol/L	at 07:30 am in fasted condition during one day
blood N-terminal pro-B natriuretic peptide	blood N-terminal pro-B natriuretic peptide level in g/L	at 07:30 am in fasted condition during one day
blood troponin	blood troponin level in g/L	at 07:30 am in fasted condition during one day
blood lipids	blood lipids level in g/L	at 07:30 am in fasted condition during one day
blood glucose	blood glucose level in g/L	at 07:30 am in fasted condition during one day
Body composition: fat	percentage of fat	at 07:30 am during one day
Body composition: lean mass	percentage of lean mass	at 07:30 am during one day
cardiac output	Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise	at 11:30 am during one day
peripheral quantitative computed tomography	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	at 10:45 am during one day
physical condition	3 min step-test (number of ascent / descent step)	at 08:45 am during one day
physical capacity	chair test (time in second held in position)	at 08:45 am during one day
physical activity level	daily energy expenditure (in Kcal)	from day 2 to day 5
sedentary level	total sedentary time (in min) evaluated by accelerometer for 4 days	from day 2 to day 5

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: exercise; metabolism; physical fitness; fat oxidation
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: RBHP 2021 KANOLD; 2021-A02184-37 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No