LymphomaLYMfitNCT06270667
Effects of Exercise Training in Survivors of Lymphoma
A study testing Aerobic Exercise and Combined Aerobic and Resistance Exercise in people with Lymphoma and Physical Exercise, run by Norwegian School of Sport Sciences at 2 sites in 2 countries.
Trial summary
This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Physical Exercise, Cardiotoxicity
- What is being tested?
- Aerobic Exercise and Combined Aerobic and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Mar 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Listed in relevant registers
- Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma)
- Completed treatment in the past two to five years without relapse or second cancer
- Previous anthracycline treatment with or without mediastinal radiation
- No severe cancer-related fatigue (per self-report)
- Inclusion Criteria Lymphoma participants and non-cancer reference group:
- Currently not performing >75 minutes/week of aerobic exercise
- Willing and able to adhere to all study procedures.
Who cannot join
- Relapse since diagnosis
- A history, or current presence, of another diagnosis of invasive cancer of any kind
- Exclusion Criteria Lymphoma participants and non-cancer reference group:
- Presence of any uncontrolled- or recent cardiovascular disease
- Has undergone heart surgery
- Uses a pacemaker
Show all 10Show fewer
- Pregnancy
- Unable to read and understand Swedish (applicable for the Swedish site only)
- Unable to read and understand Norwegian (applicable for the Norwegian site)
- Any physical or mental health condition restricting adherence to study protocol
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Norway1 site, 1 recruiting
- Not yet recruiting
Norweigan School of Sport Sciences
Oslo
Tormod S. Nilsen, PhD
Sweden1 site, 1 recruiting
- Recruiting
Helena Igelström
Uppsala
Helena Igelström, PhD
Anna Henriksson, PhD, 709394175 ext. 0046, anna.km.henriksson@uu.se
About this study
Official title: The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors
This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.
Read the detailed description
In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.
- Conditions
- Lymphoma, Physical Exercise, Cardiotoxicity, Cardiovascular Diseases, Chemotherapeutic Toxicity
- Being tested
- Aerobic Exercise, Combined Aerobic and Resistance Exercise
- Medical subject headings
- Lymphoma, Motor Activity, Cardiotoxicity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group)
Combined Aerobic and Resistance ExerciseBehavioural
Twice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Aerobic Exercise twice weekly for 5 months. Receives: Behavioral: Aerobic Exercise |
| Combined Aerobic and Resistance Exercise | Experimental | Combined Aerobic and Resistance Exercise twice weekly for 5 months. Receives: Behavioral: Combined Aerobic and Resistance Exercise |
| Standard Care | No intervention | Standard Care, i.e no exercise intervention. |
| Reference Aerobic Exercise | Active comparator | Aerobic Exercise twice weekly for 5 months. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Secondary outcomes (15)
Systolic- and diastolic heart chamber dimensions
Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Systolic- and diastolic longitudinal strain
Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Lean body mass
Body composition will be assessed by dual x-ray absorptiometry
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Fat mass
Body composition will be assessed by dual x-ray absorptiometry
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Forced Vital Capacity
Lung function are assessed with spirometry.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Forced Expiratory Volume 1 sec
Lung function are assessed with spirometry.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Maximal voluntary ventilation
Lung function are assessed with spirometry.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Diffusion capacity
Diffusion capacity for carbon monoxide is assessed with single breath diffusion capacity test.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Physical activity
Actigraph accelerometer with physical activity diary. 7 days consecutive measurement at each timepoints.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Physical activity
Patient reported physical activity is assessed with Godin Leisure-Time Exercise Questionnaire
Measured: Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Global Health related Quality of life
Patient reported health related quality of life will be assessed with EORTC QLQ C 30
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Blood volume
Will be assessed in Norway only. Using the carbon monoxide rebreathing method.
Measured: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Muscle fiber area
Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Measured: Baseline, five months from baseline (i.e. end of intervention)
Muscle fiber type
Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Measured: Baseline, five months from baseline (i.e. end of intervention)
Muscle mitochondria mass
Will be assessed in Norway only. Change in mitochondrial proteins will be assessed in muscle biopsies using western blot
Measured: Baseline, five months from baseline (i.e. end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Mar 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Tormod Skogstad Nilsen, Norwegian School of Sport Sciences
- Investigators
- Tormod S. Nilsen, PhD, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270667
- Sponsor's protocol ID
- LYMfit
- Acronym
- LYMfit
- Status last verified
- Mar 2024
- First submitted
- 19 Jan 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT06270667
- Acronym / sponsor ID
- LYMfit / LYMfit
- Conditions
- Lymphoma, Physical Exercise, Cardiotoxicity, Cardiovascular Diseases, Chemotherapeutic Toxicity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Feb 2024 (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.
This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.
Detailed description
In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseAerobic Exercise twice weekly for 5 months. |
| Combined Aerobic and Resistance Exercise | Experimental | Behavioral: Combined Aerobic and Resistance ExerciseCombined Aerobic and Resistance Exercise twice weekly for 5 months. |
| Standard Care | No intervention | –Standard Care, i.e no exercise intervention. |
| Reference Aerobic Exercise | Active comparator | Behavioral: Aerobic ExerciseAerobic Exercise twice weekly for 5 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Listed in relevant registers
- Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma)
- Completed treatment in the past two to five years without relapse or second cancer
- Previous anthracycline treatment with or without mediastinal radiation
- No severe cancer-related fatigue (per self-report)
Key exclusion criteria (10 listed)
- Relapse since diagnosis
- A history, or current presence, of another diagnosis of invasive cancer of any kind
- Presence of any uncontrolled- or recent cardiovascular disease
- Has undergone heart surgery
- Uses a pacemaker
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 |
|---|---|---|
| Aerobic ExerciseParticipants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group) | Behavioural | Aerobic Exercise, Reference Aerobic Exercise |
| Combined Aerobic and Resistance ExerciseTwice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm. | Behavioural | Combined Aerobic and Resistance Exercise |
Primary outcome
VO2peak
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test
15 secondary outcomes
Systolic- and diastolic heart chamber dimensions
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Systolic- and diastolic longitudinal strain
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Lean body mass
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Fat mass
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Forced Vital Capacity
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Forced Expiratory Volume 1 sec
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Maximal voluntary ventilation
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Diffusion capacity
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Physical activity
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Physical activity
Time frame: Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Global Health related Quality of life
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Blood volume
Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Muscle fiber area
Time frame: Baseline, five months from baseline (i.e. end of intervention)
Muscle fiber type
Time frame: Baseline, five months from baseline (i.e. end of intervention)
Muscle mitochondria mass
Time frame: Baseline, five months from baseline (i.e. end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Tormod S. Nilsen, PhD principal investigator
Norwegian School of Sport Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Combined Aerobic and Resistance Exercise in people with Lymphoma and Physical Exercise, run by Norwegian School of Sport Sciences at 2 sites in 2 countries.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tormod S. Nilsen, PhD (95069857 ext. 0047, tormodsn@nih.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline). 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 22 Mar 2024.