Fitness Assessment in Young Adults Recovered From Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

— CUPCAKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188755
• Other study ID #: RBHP 2021 KANOLD
• Secondary ID: 2021-A02184-37
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: November 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Young Adults

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fat oxidation rate	maximum rate of lipid oxidation (in mg/ml)	day at 11:30 am during one day
Secondary	rest metabolism	energy expenditure at rest in kcal.	at 08:00 am in fasted condition during one day
Secondary	blood insulinemia	blood value of insulin in pmol/L	at 07:30 am in fasted condition during one day
Secondary	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
Secondary	blood troponin	blood troponin level in g/L	at 07:30 am in fasted condition during one day
Secondary	blood lipids	blood lipids level in g/L	at 07:30 am in fasted condition during one day
Secondary	blood glucose	blood glucose level in g/L	at 07:30 am in fasted condition during one day
Secondary	Body composition: fat	percentage of fat	at 07:30 am during one day
Secondary	Body composition: lean mass	percentage of lean mass	at 07:30 am during one day
Secondary	cardiac output	Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise	at 11:30 am during one day
Secondary	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
Secondary	physical condition	3 min step-test (number of ascent / descent step)	at 08:45 am during one day
Secondary	physical capacity	chair test (time in second held in position)	at 08:45 am during one day
Secondary	physical activity level	daily energy expenditure (in Kcal)	from day 2 to day 5
Secondary	sedentary level	total sedentary time (in min) evaluated by accelerometer for 4 days	from day 2 to day 5