Clinical trial NCT06270667: Effects of Exercise Training in Survivors of Lymphoma
Official title: The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Physical Exercise
Cardiotoxicity
Cardiovascular Diseases
Chemotherapeutic Toxicity
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2024-02-21
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria Lymphoma participants:

* 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.

Exclusion Criteria Lymphoma participants:

* 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
* 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

Primary outcomes:
measure: VO2peak
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Secondary outcomes:
measure: Systolic- and diastolic heart chamber dimensions
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Systolic- and diastolic longitudinal strain
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Lean body mass
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Fat mass
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Forced Vital Capacity
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Forced Expiratory Volume 1 sec
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Maximal voluntary ventilation
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Diffusion capacity
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Physical activity
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Physical activity
timeFrame: Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Global Health related Quality of life
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Blood volume
timeFrame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
measure: Muscle fiber area
timeFrame: Baseline, five months from baseline (i.e. end of intervention)
measure: Muscle fiber type
timeFrame: Baseline, five months from baseline (i.e. end of intervention)
measure: Muscle mitochondria mass
timeFrame: Baseline, five months from baseline (i.e. end of intervention)
Other outcomes:
measure: Muscle genome-wide DNA methylation and gene expression
timeFrame: Baseline, five months from baseline (i.e. end of intervention)
measure: Adverse events
timeFrame: Five months from baseline (i.e. end of intervention)
Locations:
city: Oslo
country: Norway
facility: Norweigan School of Sport Sciences
city: Uppsala
country: Sweden
facility: Helena Igelström
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Tormod S. Nilsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: