STAY-STRONG Study of Exercise Training During Chemotherapy

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05556239
Collaborator
(none)
60
1
2
27
2.2

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial.
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Lean Body Mass [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan.

Secondary Outcome Measures

  1. Functional performance: Habitual gait speed [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in habitual gait speed. Assessed using a 10-Meter walk test

  2. Functional performance: Maximal gait speed [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in maximal gait speed assessed using a 10-Meter walk test

  3. Functional performance: Stair climbing power [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in stair climbing power following a fixed protocol.

  4. Functional performance: Sit-to-stand [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS)

  5. Muscle strength:Hand grip strength [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in Hand grip strength. Assessed by a dynamometer

  6. Muscle strength:Maximal isometric knee extensor strength [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in maximal isometric knee extensor strength. Assessed by a dynamometer

  7. Leg-extensor power [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in maximum leg power assessed by Nottingham Power Rig

  8. Health Related Quality of Life [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    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)

  9. Symptoms burden [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

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

  10. Depression and Anxiety. [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

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

  11. Leisure time physical activity [Baseline, 4-month follow-up]

    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.

  12. Inflammation marker: Tumor necrosis factor alpha (TNF- α) [Baseline, 4-month follow-up]

    Changes in blood TNF- α concentration

  13. Inflammation marker: interleukin (IL)-13 [Baseline, 4-month follow-up]

    Changes in blood IL-13 concentration

  14. Inflammation marker: Interleukin (IL)-6 [Baseline, 4-month follow-up]

    Changes in blood IL-6 concentration

  15. Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) [Baseline, 4-month follow-up]

    Changes in blood hsCRP concentration

  16. Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) [Baseline, 4-month follow-up]

    Changes in blood GDF11 concentration

  17. Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) [Baseline, 4-month follow-up]

    Changes in blood GDF15 concentration

  18. Body composition and anthropometrics: Fat percentage [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in whole-body fat percentage assessed by DXA scan.

  19. Body composition and anthropometrics: Body mass [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in body mass

  20. Body composition and anthropometrics: Total fat mass [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in total fat mass, assessed by DXA

  21. Body composition and anthropometrics: Body mass index (BMI) [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    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)

  22. Exercise feasibility: Exercise sessions attendance rate [From baseline to 4-month follow-up]

    Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

  23. 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]

    Changes in patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)

Other Outcome Measures

  1. Muscle biopsies [Baseline, 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,

  2. Muscle Architecture: Muscle Thickness [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in muscle thickness will be assessed by ultrasound imaging.

  3. Muscle Architecture: Pennation Angle [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

    Changes in pennation angle will be assessed by ultrasound imaging.

  4. Self-reported physical activity [Baseline]

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

  5. Nutrition [Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Christensen, Senior researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05556239
Other Study ID Numbers:
  • H-22014826
First Posted:
Sep 27, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2022