Effects of Exercise Training in Survivors of Lymphoma (LYMfit)

Norwegian School of Sport Sciences

Status: Enrolling

Conditions: Cardiotoxicity; Chemotherapeutic Toxicity; Cardiovascular Diseases; Lymphoma; Physical Exercise

Treatments: Behavioral: Aerobic Exercise; Behavioral: Combined Aerobic and Resistance Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06270667

LYMfit

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

Aerobic Exercise

Experimental group

Description:

Aerobic Exercise twice weekly for 5 months.

Treatment:

Behavioral: Aerobic Exercise

Combined Aerobic and Resistance Exercise

Experimental group

Description:

Combined Aerobic and Resistance Exercise twice weekly for 5 months.

Treatment:

Behavioral: Combined Aerobic and Resistance Exercise

Standard Care

No Intervention group

Description:

Standard Care, i.e no exercise intervention.

Reference Aerobic Exercise

Active Comparator group

Description:

Aerobic Exercise twice weekly for 5 months.

Treatment:

Behavioral: Aerobic Exercise