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STAY-STRONG Study of Exercise Training During Chemotherapy

Rigshospitalet logo

Rigshospitalet

Status

Active, not recruiting

Conditions

Lymphoma, B-Cell
Lymphoma, Hodgkin
Quality of Life
Patient Reported Outcome Measures
Muscle, Skeletal
Physical Functional Performance
Sarcopenia
Body Composition
Exercise

Treatments

Behavioral: Resistance Exercise Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05556239
H-22014826

Details and patient eligibility

About

This study evaluates the effectiveness of a supervised progressive resistance training program in patients malignant lymphomas with the primary outcome being lean body mass.

The study is designed as a a single center, two-armed, parallel-group, investigator-initiated clinical randomized controlled superiority trail evaluating the effectiveness of a 4-month supervised progressive resistance training intervention compared to usual care.

Full description

New approaches of early rehabilitation are needed to maintain physical function levels in patients with malignant lymphoma patients during chemotherapy treatment. The STAY STRONG TRAIL has the potential to become the future model of care and rehabilitation with the prospect of reducing the complex symptom burden, supporting treatment tolerance, maintaining physical function and, by extension, improve the patient's chances of survival and quality of life. This study will be among the first to include structured and supervised progressive resistance training during the complete 1st line anthracycline-containing combination chemotherapy regime in patients treated with Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma.

At present, there is a lack of knowledge regarding the potential effect of exercise to counteract muscle atrophy during chemotherapy in patients with malignant lymphomas. The overall aim of the present STAY STRONG TRAIL is to investigate whether a structured and supervised progressive resistance training program during the complete first line anthracycline-containing combination chemotherapy with support from an 'exercise ambassador' can preserve muscle function and prevent muscle dysfunction in patients newly diagnosed with Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma referred to first line treatment.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must:

    • Be newly diagnosed with diffuse large B-cell lymphoma and Hodgkin Lymphoma
    • Be expected to receive treatment with an anthracycline-containing combination chemotherapy at the Department of Hematology, Rigshospitalet
    • Be ≥ 18 years of age at the time of signing the informed consent form.
    • Be residing in Denmark
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
    • Be able to speak and read Danish, and to provide a signed informed consent form.

Exclusion criteria

  • Patients with:

    • Clinically significant cardiovascular disease, including, but not limited to: Heart failure NYHA (New York Heart Association) class III-IV, uncontrolled hypertension, and symptomatic cardiac arrhythmias.
    • Psychiatric, neurological, or geographical conditions that could influence protocol adherence.
    • Disorders that cause an inability to perform exercise training for one hour.
    • Any other known malignancy requiring active treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

The usual care group
No Intervention group
Description:
The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet
Resistance Exercise Training
Experimental group
Description:
Patients included in the intervention group will receive usual care plus the exercise training intervention.
Treatment:
Behavioral: Resistance Exercise Training

Trial contacts and locations

1

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Central trial contact

Jan Christensen, PhD; Charlotte N Groenset, PhD-student

Data sourced from clinicaltrials.gov

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