STAY-STRONG Study of Exercise Training During Chemotherapy (STAY-STRONG)

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

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.

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.

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

The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet

Patients included in the intervention group will receive usual care plus the exercise training intervention.

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.

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)

Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI)

Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).

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.

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 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

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,

Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form)

Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ)

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.