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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05556239
Other study ID # H-22014826
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2022
Est. completion date January 1, 2025

Study information

Verified date April 2023
Source Rigshospitalet, Denmark
Contact Jan Christensen, PhD
Phone 004535458511
Email jan.christensen.02@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date January 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Resistance 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.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Muscle biopsies 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, Baseline, 4-month follow-up
Other Muscle Architecture: Muscle Thickness Changes in muscle thickness will be assessed by ultrasound imaging. Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Other Muscle Architecture: Pennation Angle Changes in pennation angle will be assessed by ultrasound imaging. Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Other Self-reported physical activity Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form) Baseline
Other Nutrition Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ) Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Inflammation marker: Tumor necrosis factor alpha (TNF- a) Changes in blood TNF- a concentration Baseline, 4-month follow-up
Secondary Inflammation marker: interleukin (IL)-13 Changes in blood IL-13 concentration Baseline, 4-month follow-up
Secondary Inflammation marker: Interleukin (IL)-6 Changes in blood IL-6 concentration Baseline, 4-month follow-up
Secondary Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) Changes in blood hsCRP concentration Baseline, 4-month follow-up
Secondary Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) Changes in blood GDF11 concentration Baseline, 4-month follow-up
Secondary Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) Changes in blood GDF15 concentration Baseline, 4-month follow-up
Secondary 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
Secondary Body composition and anthropometrics: Body mass Changes in body mass Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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