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Fitness Assessment in Young Adults Recovered From Lymphoma (CUPCAKE)

Primary Purpose

Young Adults, Lymphoma, Non-Hodgkin, Hodgkin Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Indirect calorimetric test during submaximal exercise
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Young Adults focused on measuring physical fitness, fat oxidation, metabolism, exercise

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy controls

young adults recovered from lymphoma or Hodgkin's disease

Arm Description

sex and age matched healthy controls

young adults recovered from lymphoma or Hodgkin's disease

Outcomes

Primary Outcome Measures

fat oxidation rate
maximum rate of lipid oxidation (in mg/ml)

Secondary Outcome Measures

rest metabolism
energy expenditure at rest in kcal.
blood insulinemia
blood value of insulin in pmol/L
blood N-terminal pro-B natriuretic peptide
blood N-terminal pro-B natriuretic peptide level in g/L
blood troponin
blood troponin level in g/L
blood lipids
blood lipids level in g/L
blood glucose
blood glucose level in g/L
Body composition: fat
percentage of fat
Body composition: lean mass
percentage of lean mass
cardiac output
Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise
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
physical condition
3 min step-test (number of ascent / descent step)
physical capacity
chair test (time in second held in position)
physical activity level
daily energy expenditure (in Kcal)
sedentary level
total sedentary time (in min) evaluated by accelerometer for 4 days

Full Information

First Posted
November 29, 2021
Last Updated
December 22, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05188755
Brief Title
Fitness Assessment in Young Adults Recovered From Lymphoma
Acronym
CUPCAKE
Official Title
Fitness Assessment in Young Adults Recovered From Lymphoma or Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Young Adults, Lymphoma, Non-Hodgkin, Hodgkin Disease
Keywords
physical fitness, fat oxidation, metabolism, exercise

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
sex and age matched healthy controls
Arm Title
young adults recovered from lymphoma or Hodgkin's disease
Arm Type
Experimental
Arm Description
young adults recovered from lymphoma or Hodgkin's disease
Intervention Type
Other
Intervention Name(s)
Indirect calorimetric test during submaximal exercise
Other Intervention Name(s)
cardiac output, body composition, assessment of physical capacity, blood test, accelerometry, peripheral quantitative computed tomography
Intervention Description
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
Primary Outcome Measure Information:
Title
fat oxidation rate
Description
maximum rate of lipid oxidation (in mg/ml)
Time Frame
day at 11:30 am during one day
Secondary Outcome Measure Information:
Title
rest metabolism
Description
energy expenditure at rest in kcal.
Time Frame
at 08:00 am in fasted condition during one day
Title
blood insulinemia
Description
blood value of insulin in pmol/L
Time Frame
at 07:30 am in fasted condition during one day
Title
blood N-terminal pro-B natriuretic peptide
Description
blood N-terminal pro-B natriuretic peptide level in g/L
Time Frame
at 07:30 am in fasted condition during one day
Title
blood troponin
Description
blood troponin level in g/L
Time Frame
at 07:30 am in fasted condition during one day
Title
blood lipids
Description
blood lipids level in g/L
Time Frame
at 07:30 am in fasted condition during one day
Title
blood glucose
Description
blood glucose level in g/L
Time Frame
at 07:30 am in fasted condition during one day
Title
Body composition: fat
Description
percentage of fat
Time Frame
at 07:30 am during one day
Title
Body composition: lean mass
Description
percentage of lean mass
Time Frame
at 07:30 am during one day
Title
cardiac output
Description
Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise
Time Frame
at 11:30 am during one day
Title
peripheral quantitative computed tomography
Description
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
Time Frame
at 10:45 am during one day
Title
physical condition
Description
3 min step-test (number of ascent / descent step)
Time Frame
at 08:45 am during one day
Title
physical capacity
Description
chair test (time in second held in position)
Time Frame
at 08:45 am during one day
Title
physical activity level
Description
daily energy expenditure (in Kcal)
Time Frame
from day 2 to day 5
Title
sedentary level
Description
total sedentary time (in min) evaluated by accelerometer for 4 days
Time Frame
from day 2 to day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justina Kanold
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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Fitness Assessment in Young Adults Recovered From Lymphoma

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