Clinical trial NCT05556239: STAY-STRONG Study of Exercise Training During Chemotherapy
Official title: The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphoma, B-Cell
Lymphoma, Hodgkin
Exercise
Body Composition
Physical Functional Performance
Quality of Life
Sarcopenia
Muscle, Skeletal
Patient Reported Outcome Measures
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lean Body Mass
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Secondary outcomes:
measure: Functional performance: Habitual gait speed
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Functional performance: Maximal gait speed
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Functional performance: Stair climbing power
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Functional performance: Sit-to-stand
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Muscle strength:Hand grip strength
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Muscle strength:Maximal isometric knee extensor strength
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Leg-extensor power
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Health Related Quality of Life
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Symptoms burden
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Depression and Anxiety.
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Leisure time physical activity
timeFrame: Baseline, 4-month follow-up
measure: Inflammation marker: Tumor necrosis factor alpha (TNF- α)
timeFrame: Baseline, 4-month follow-up
measure: Inflammation marker: interleukin (IL)-13
timeFrame: Baseline, 4-month follow-up
measure: Inflammation marker: Interleukin (IL)-6
timeFrame: Baseline, 4-month follow-up
measure: Inflammation markers: High-sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline, 4-month follow-up
measure: Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11)
timeFrame: Baseline, 4-month follow-up
measure: Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15)
timeFrame: Baseline, 4-month follow-up
measure: Body composition and anthropometrics: Fat percentage
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Body composition and anthropometrics: Body mass
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Body composition and anthropometrics: Total fat mass
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Body composition and anthropometrics: Body mass index (BMI)
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Exercise feasibility: Exercise sessions attendance rate
timeFrame: From baseline to 4-month follow-up
measure: Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)
timeFrame: Immediately before and immediately after each exercise session performed from baseline to 4-month follow-up
Other outcomes:
measure: Muscle biopsies
timeFrame: Baseline, 4-month follow-up
measure: Muscle Architecture: Muscle Thickness
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Muscle Architecture: Pennation Angle
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
measure: Self-reported physical activity
timeFrame: Baseline
measure: Nutrition
timeFrame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: