STAY-STRONG Study of Exercise Training During Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial.

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

Intervention / Treatment
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* Behavioral: Resistance Exercise Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: The usual care group<br>The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet | |
| Experimental: Resistance Exercise Training<br>Patients included in the intervention group will receive usual care plus the exercise training intervention. | Behavioral: Resistance Exercise Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean Body Mass | Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance: Habitual gait speed | Changes in habitual gait speed. Assessed using a 10-Meter walk test | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Functional performance: Maximal gait speed | Changes in maximal gait speed assessed using a 10-Meter walk test | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Functional performance: Stair climbing power | Changes in stair climbing power following a fixed protocol. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Functional performance: Sit-to-stand | Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Muscle strength:Hand grip strength | Changes in Hand grip strength. Assessed by a dynamometer | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Muscle strength:Maximal isometric knee extensor strength | Changes in maximal isometric knee extensor strength. Assessed by a dynamometer | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Leg-extensor power | Changes in maximum leg power assessed by Nottingham Power Rig | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Health Related Quality of Life | 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) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Symptoms burden | Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Depression and Anxiety. | Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS). | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Leisure time physical activity | 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. | Baseline, 4-month follow-up | 
| Inflammation marker: Tumor necrosis factor alpha (TNF- α) | Changes in blood TNF- α concentration | Baseline, 4-month follow-up | 
| Inflammation marker: interleukin (IL)-13 | Changes in blood IL-13 concentration | Baseline, 4-month follow-up | 
| Inflammation marker: Interleukin (IL)-6 | Changes in blood IL-6 concentration | Baseline, 4-month follow-up | 
| Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) | Changes in blood hsCRP concentration | Baseline, 4-month follow-up | 
| Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) | Changes in blood GDF11 concentration | Baseline, 4-month follow-up | 
| Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) | Changes in blood GDF15 concentration | Baseline, 4-month follow-up | 
| Body composition and anthropometrics: Fat percentage | Changes in whole-body fat percentage assessed by DXA scan. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Body composition and anthropometrics: Body mass | Changes in body mass | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Body composition and anthropometrics: Total fat mass | Changes in total fat mass, assessed by DXA | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Body composition and anthropometrics: Body mass index (BMI) | 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) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | 
| Exercise feasibility: Exercise sessions attendance rate | Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100 | From baseline to 4-month follow-up | 
| Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other) | Changes in 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 |