STAY-STRONG Study of Exercise Training During Chemotherapy

Trial Title: STAY-STRONG Study of Exercise Training During Chemotherapy

NCT ID: NCT05556239

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

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Hodgkin Disease
Sarcopenia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Resistance Exercise Training
Description: 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.
Arm group label: Resistance Exercise Training

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Rigshospitalet

Address:
City: Copenhagen
Country: Denmark

Status: Recruiting

Contact:
Last name: Jan Christensen, Senior researcher

Start date: October 25, 2022

Completion date: January 1, 2025

Lead sponsor:
Agency: Rigshospitalet, Denmark
Agency class: Other

Source: Rigshospitalet, Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05556239