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NCT Number: NCT06270667

Effects of Exercise Training in Survivors of Lymphoma

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.

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Key information

Conditions

Lymphoma Behavior Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Toxicity Drug-Related Side Effects and Adverse Reactions Heart Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Exercise Radiation Injuries Wounds and Injuries

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norweigan School of Sport Sciences, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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 Exercise

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Systolic- and diastolic heart chamber dimensions

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)

  2. Systolic- and diastolic longitudinal strain

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)

  3. Lean body mass

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Body composition will be assessed by dual x-ray absorptiometry

  4. Fat mass

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Body composition will be assessed by dual x-ray absorptiometry

  5. Forced Vital Capacity

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Lung function are assessed with spirometry.

  6. Forced Expiratory Volume 1 sec

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Lung function are assessed with spirometry.

  7. Maximal voluntary ventilation

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Lung function are assessed with spirometry.

  8. Diffusion capacity

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Diffusion capacity for carbon monoxide is assessed with single breath diffusion capacity test.

  9. Physical activity

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Actigraph accelerometer with physical activity diary. 7 days consecutive measurement at each timepoints.

  10. Physical activity

    Time frame: Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Patient reported physical activity is assessed with Godin Leisure-Time Exercise Questionnaire

  11. Global Health related Quality of life

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Patient reported health related quality of life will be assessed with EORTC QLQ C 30

  12. Blood volume

    Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

    Will be assessed in Norway only. Using the carbon monoxide rebreathing method.

  13. Muscle fiber area

    Time frame: Baseline, five months from baseline (i.e. end of intervention)

    Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry

  14. Muscle fiber type

    Time frame: Baseline, five months from baseline (i.e. end of intervention)

    Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry

  15. Muscle mitochondria mass

    Time frame: Baseline, five months from baseline (i.e. end of intervention)

    Will be assessed in Norway only. Change in mitochondrial proteins will be assessed in muscle biopsies using western blot

Other outcomes

  1. Muscle genome-wide DNA methylation and gene expression

    Time frame: Baseline, five months from baseline (i.e. end of intervention)

    Will be assessed in Norway only. For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA

  2. Adverse events

    Time frame: Five months from baseline (i.e. end of intervention)

    Medical records and Patient reported outcome version of the Common Terminology Criteria for Adverse Events.

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Igelström, PhD

CONTACT

[email protected]

729999599 ext. 0046

Tormod S. Nilsen, PhD

CONTACT

[email protected]

95069857 ext. 0047

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • Uppsala University

Registry information

Official study title

The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors

Acronym: LYMfit

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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