Young AdultsCUPCAKENCT05188755
Fitness Assessment in Young Adults Recovered From Lymphoma
A study testing Indirect calorimetric test during submaximal exercise in people with Young Adults and Lymphoma, Non-Hodgkin, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Adults, Lymphoma, Non-Hodgkin, Hodgkin Disease
- What is being tested?
- Indirect calorimetric test during submaximal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Active infection
- Pregnant, breastfeeding, or likely to be
- Subject's refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Young Adults, Lymphoma, Non-Hodgkin, Hodgkin Disease
- Being tested
- Indirect calorimetric test during submaximal exercise
- Keywords
- physical fitness, fat oxidation, metabolism, exercise
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetric test during submaximal exerciseOther
Also called cardiac output, body composition, assessment of physical capacity, blood test
- 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
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Active comparator | sex and age matched healthy controls Receives: Other: Indirect calorimetric test during submaximal exercise |
| young adults recovered from lymphoma or Hodgkin's disease | Experimental | young adults recovered from lymphoma or Hodgkin's disease Receives: Other: Indirect calorimetric test during submaximal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat oxidation rate
maximum rate of lipid oxidation (in mg/ml)
Measured: day at 11:30 am during one day
Secondary outcomes (14)
rest metabolism
energy expenditure at rest in kcal.
Measured: at 08:00 am in fasted condition during one day
blood insulinemia
blood value of insulin in pmol/L
Measured: 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
Measured: at 07:30 am in fasted condition during one day
blood troponin
blood troponin level in g/L
Measured: at 07:30 am in fasted condition during one day
blood lipids
blood lipids level in g/L
Measured: at 07:30 am in fasted condition during one day
blood glucose
blood glucose level in g/L
Measured: at 07:30 am in fasted condition during one day
Body composition: fat
percentage of fat
Measured: at 07:30 am during one day
Body composition: lean mass
percentage of lean mass
Measured: at 07:30 am during one day
cardiac output
Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise
Measured: 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
Measured: at 10:45 am during one day
physical condition
3 min step-test (number of ascent / descent step)
Measured: at 08:45 am during one day
physical capacity
chair test (time in second held in position)
Measured: at 08:45 am during one day
physical activity level
daily energy expenditure (in Kcal)
Measured: from day 2 to day 5
sedentary level
total sedentary time (in min) evaluated by accelerometer for 4 days
Measured: from day 2 to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jan 2022
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young AdultsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justina Kanold, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188755
- Sponsor's protocol ID
- RBHP 2021 KANOLD
- Other IDs
- 2021-A02184-37
- Acronym
- CUPCAKE
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness Assessment in Young Adults Recovered From Lymphoma or Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT05188755
- Acronym / sponsor ID
- CUPCAKE / RBHP 2021 KANOLD
- Conditions
- Young Adults, Lymphoma, Non-Hodgkin, Hodgkin Disease
- Keywords
- physical fitness, fat oxidation, metabolism, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group 1: healthy controls group 2 : young adults recovered from lymphoma or Hodgkin's disease
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Active comparator | Other: Indirect calorimetric test during submaximal exercisesex and age matched healthy controls |
| young adults recovered from lymphoma or Hodgkin's disease | Experimental | Other: Indirect calorimetric test during submaximal exerciseyoung adults recovered from lymphoma or Hodgkin's disease |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect calorimetric test during submaximal exerciseAlso: cardiac output, body composition, assessment of physical capacity, blood test* 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 | Healthy controls, young adults recovered from lymphoma or Hodgkin's disease |
Primary outcome
fat oxidation rate
Time frame: day at 11:30 am during one day
maximum rate of lipid oxidation (in mg/ml)
14 secondary outcomes
rest metabolism
Time frame: at 08:00 am in fasted condition during one day
blood insulinemia
Time frame: at 07:30 am in fasted condition during one day
blood N-terminal pro-B natriuretic peptide
Time frame: at 07:30 am in fasted condition during one day
blood troponin
Time frame: at 07:30 am in fasted condition during one day
blood lipids
Time frame: at 07:30 am in fasted condition during one day
blood glucose
Time frame: at 07:30 am in fasted condition during one day
Body composition: fat
Time frame: at 07:30 am during one day
Body composition: lean mass
Time frame: at 07:30 am during one day
cardiac output
Time frame: at 11:30 am during one day
peripheral quantitative computed tomography
Time frame: at 10:45 am during one day
physical condition
Time frame: at 08:45 am during one day
physical capacity
Time frame: at 08:45 am during one day
physical activity level
Time frame: from day 2 to day 5
sedentary level
Time frame: from day 2 to day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justina Kanold principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect calorimetric test during submaximal exercise in people with Young Adults and Lymphoma, Non-Hodgkin, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat oxidation rate (time frame: day at 11:30 am during one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.