Body Composition, Exercise, Lymphoma, B-Cell, Lymphoma, Hodgkin, Muscle, Skeletal, Patient Reported Outcome Measures, Physical Functional Performance, Quality of Life, Sarcopenia
Conditions
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.
Interventions
BEHAVIORALResistance Exercise Training
Supervised resistance training program planned as 3 sessions per week of approximately 60 minutes. The resistance training program comprises 6 exercises for the major muscle groups, starting at 2 sets of 15 repetitions maximum progressing to 4 sets of 8 repetitions maximum. Each session will be supervised by physiotherapist to ensure proper technique, and progression in training load. The participants will choose an exercise ambassador from their network, who during the period will be encouraged to, on a weekly basis, to be in contact with the participant.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lean Body Mass | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression and Anxiety. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS). |
| Body composition and anthropometrics: Body mass | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in body mass |
| Body composition and anthropometrics: Total fat mass | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in total fat mass, assessed by DXA |
| Body composition and anthropometrics: Body mass index (BMI) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in BMI. Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m\^2) |
| Exercise feasibility: Exercise sessions attendance rate | From baseline to 4-month follow-up | Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100 |
| Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other) | Immediately before and immediately after each exercise session performed from baseline to 4-month follow-up | Changes in patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other) |
| Functional performance: Habitual gait speed | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in habitual gait speed. Assessed using a 10-Meter walk test |
| Functional performance: Maximal gait speed | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in maximal gait speed assessed using a 10-Meter walk test |
| Functional performance: Stair climbing power | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in stair climbing power following a fixed protocol. |
| Functional performance: Sit-to-stand | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS) |
| Muscle strength:Hand grip strength | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in Hand grip strength. Assessed by a dynamometer |
| Muscle strength:Maximal isometric knee extensor strength | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in maximal isometric knee extensor strength. Assessed by a dynamometer |
| Leg-extensor power | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in maximum leg power assessed by Nottingham Power Rig |
| Health Related Quality of Life | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in patient-reported health-related quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire EORTC (EORTC-QLQ-C30) |
| Symptoms burden | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI) |
| Leisure time physical activity | Baseline, 4-month follow-up | Changes in leisure time physical activity. Assessed by activity accelerometer (ActiGraph wGT3x-BT). Participants will be instructed to wear the accelerometer at their waist for 24 h during ten consecutive days. |
| Inflammation marker: Tumor necrosis factor alpha (TNF- α) | Baseline, 4-month follow-up | Changes in blood TNF- α concentration |
| Inflammation marker: interleukin (IL)-13 | Baseline, 4-month follow-up | Changes in blood IL-13 concentration |
| Inflammation marker: Interleukin (IL)-6 | Baseline, 4-month follow-up | Changes in blood IL-6 concentration |
| Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) | Baseline, 4-month follow-up | Changes in blood hsCRP concentration |
| Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) | Baseline, 4-month follow-up | Changes in blood GDF11 concentration |
| Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) | Baseline, 4-month follow-up | Changes in blood GDF15 concentration |
| Body composition and anthropometrics: Fat percentage | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in whole-body fat percentage assessed by DXA scan. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Muscle Architecture: Pennation Angle | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in pennation angle will be assessed by ultrasound imaging. |
| Self-reported physical activity | Baseline | Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form) |
| Nutrition | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ) |
| Muscle Architecture: Muscle Thickness | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | Changes in muscle thickness will be assessed by ultrasound imaging. |
| Muscle biopsies | Baseline, 4-month follow-up | Muscle biopsies will be taken on a selected number of subjects from the vastus lateralis muscle, for the use in future analysis of i.e. muscle fibre size and distribution, myogenic stem cell activity, |
Countries
Denmark
Outcome results
None listed