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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Lymphoma, B-Cell; Exercise; Body Composition; Sarcopenia; Lymphoma, Hodgkin; Physical Functional Performance; Muscle, Skeletal; Patient Reported Outcome Measures
• Intervention / Treatment: Behavioral: Resistance Exercise Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Christensen, PhD; Phone Number: 004535458511; Email: jan.christensen.02@regionh.dk
• Study Contact Backup: Name: Charlotte N Groenset, PhD-student; Phone Number: +4535459581; Email: charlotte.groenset@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Jan Christensen, Senior researcher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Lymphoma; Lymphoma, B-Cell; Hodgkin Disease; Sarcopenia
• Other Study ID Numbers: H-22014826

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No