- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586517
Effect of Heavy-load Resistance Training During Chemotherapy on Muscle Cellular Outcomes
Effects of Heavy-load Resistance Training During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to investigate the effects of heavy-load resistance training on muscle cellular outcomes in women with breast cancer undergoing (neo-)adjuvant chemotherapy.
More specifically, the investigators' objectives are to
- Investigate the effects of a heavy-load resistance training intervention on skeletal muscle fiber cross-sectional area.
- Investigate the effects of a heavy-load resistance training intervention on regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function.
- Investigate the effects of chemotherapy on skeletal muscle fiber cross-sectional area, regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function.
- Explore the effects of heavy-load resistance training on the expression levels of myokines.
This study is a two-armed randomized controlled trial with follow-up at six months. With this design, the investigators can study the main effect and interactions between factors (groups). Participants will be randomized to either an intervention group or a control group.
Participants recently diagnosed with breast cancer will be recruited from Uppsala University Hospital. Based on power calculations, 50 participants will be included. Data will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up.
Participants in the intervention group will perform supervised heavy-load resistance training twice a week from the week following the start of chemotherapy and throughout the course of treatment, approximately 16 weeks. Sessions will be performed at a public gym and led by trained coaches. The following six exercises will be included in the program: seated leg-press, seated chest press, seated leg-curl, seated row and seated leg-extension performed in machines and seated overhead-press using dumbbells. The first two weeks of the program represent familiarization to the training protocol and 1 RM (Repetition Maximum) tests. During this period, the participants will perform exercises at a light load. After the first 1 RM-test, training will progress in sets and training load before testing of 6- and 10 RM which will provide the participants with individualized loads. Rest periods between sets will be two (6 RM training load) and one minute (10 RM training load) for the two different sessions, respectively. The training load will be adjusted throughout the intervention period. Participants in the control group are encouraged to continue with their activity as usual i.e. maintain their habitual physical activity level and not initiate resistance training during chemotherapy. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy and offered a 12-month membership at a local gym, free of charge.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Uppsala, Sweden
- Uppsala University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women diagnosed with stage I-III breast cancer
- literate in Swedish
- scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of these treatments
Exclusion Criteria:
- unable to perform basic activities of daily living
- cognitive disorders or severe emotional instability
- other disabling comorbidities that might hamper physical training (e.g. severe heart failure, chronic obstructive pulmonary disease, orthopedic conditions, and neurological disorders)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Participants will receive supervised heavy-load resistance training twice a week during treatment with chemotherapy (approximately 16-weeks).
After end of chemotherapy, participants will be encouraged to continue the training program and are provided with 12-month membership at a local gym.
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Supervised heavy-load resistance training during chemotherapy treatment
Other Names:
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Active Comparator: Control group
Participants will be encouraged to continue with their usual activities during chemotherapy and not start resistance training (approximately 16-weeks).
After end of chemotherapy participants will be offered to attend a 2-week introduction to the strength-training program and provided with a 12-month membership at a local gym.
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Activity as usual during chemotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of changes in muscle fiber cross-sectional area
Time Frame: From baseline to the 16 week time-point
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Change from baseline in muscle fiber cross-sectional area at 16 weeks.
Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers
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From baseline to the 16 week time-point
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of changes in muscle fiber cross-sectional area
Time Frame: From baseline to 6-month follow-up
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Change from baseline in muscle fiber cross-sectional area at 6-month follow-up.
Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers
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From baseline to 6-month follow-up
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Assessment of changes in satellite cell content in muscle fiber cross-sections
Time Frame: From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Change from baseline in satellite cell content in muscle fiber cross-sections at 16 weeks and at 6-month follow-up.
Through immunohistochemical staining of muscle fiber cross-sections will satellite cell content be assessed per muscle fiber
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From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Assessment of changes in myonuclei content in muscle fiber cross-sections
Time Frame: From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Change from baseline in myonuclei content in muscle fiber cross-sections at 16 weeks and at 6-month follow-up.
Through immunohistochemical staining of muscle fiber cross-sections will myonuclei content be assessed per muscle fiber
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From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Assessment of protein levels of regulators of muscle fiber size (proteins involved in muscle protein synthesis and protein degradation (e.i. mTOR, MuRF, S6K1, p70S6k)
Time Frame: From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Change from baseline in protein levels of regulators of muscle fiber size at 16 weeks and at 6-month follow-up.
Proteins involved in regulation of muscle size (muscle protein synthesis and protein degradation) will be assessed in muscle homogenate using Western blot analysis
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From baseline to the 16 week time-point and from baseline to 6-month follow-up
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Assessment of changes in protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, αB-crystalline, Hsp 60 and Hsp 70)
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in protein levels of regulators of muscle fiber cellular stress at 16 weeks and at 6-month follow-up.
Proteins involved in protection against cellular stress will be assessed in muscle homogenate using Western blot analysis
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of changes in protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HAD)
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in protein levels of regulators of muscle fiber mitochondrial function at 16 weeks and at 6-month follow-up.
Proteins involved in protection/enzymes involved in mitochondrial function will be assessed in muscle homogenate using Western blot analysis
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of changes in myokines with potential anti-tumor effects
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in protein levels of myokines with potential anti-tumor effects at 16 weeks and at 6-month follow-up.
Myokines assossiated with potential anti-tumor effects will be assessed in muscle homogenate using Western blot analysis
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Changes in muscle strength
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Maximal upper- and lower extremity muscle strength will be assessed as one repetition maximum in seated chest-press and seated single-leg press
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Cardiorespiratory fitness
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Cardiorespiratory fitness will be assessed as maximal oxygen uptake during maximal walking/running until exhaustion on a treadmill
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of changes fat free mass
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in fat free mass at 16 weeks and at 6-month follow-up will be assessed using air displacement plethysmography and bioelectrical impedance analysis.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of changes in fat mass
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in fat mass at 16 weeks and at 6-month follow-up will be assessed using air displacement plethysmography and bioelectrical impedance analysis.
From this analysis fat free mass, fat mass, body density and body water content will be derived
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of blood lipids
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in blood lipids at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of C-reactive protein
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in C-reactive protein at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of creatine kinase-myocardial band
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in creatine kinase-myocardial band at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of blood glucose
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in blood glucose at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of serum cortisol
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in serum cortisol at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of hemoglobin
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in hemoglobin at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods.
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of changes in quality of life
Time Frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Change from baseline in quality of life at 16 weeks and at 6-month follow-up using The European Organization for Research and Treatment of Cancer (EORTC)EORTC-QLQ30
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From baseline to the 16 week time-point and from baseline to the 6-month follow-up
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Assessment of changes in fatigue
Time Frame: From baseline to the 16 week time point and from baseline to the 6-month follow-up
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Change from baseline in fatigue at 16 weeks and at 6-month follow-up using Multi Dimensional Fatigue Inventory (MFI)
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From baseline to the 16 week time point and from baseline to the 6-month follow-up
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Assessment of physical activity, defined as minutes spent in moderate-to-vigorous intensity activity
Time Frame: Measurement at three time points, baseline, 16 weeks and 6-month follow-up
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Assessment of physical activity, assessed by the SenseWear Armband activity monitoring device.
The purpose is to monitor and to be able to adjust for the participants' physical activity outside the intervention as a possible confounder.
A SenseWear Armband is worn for 7 consecutive days at three time points (baseline, 16 weeks and 6-month follow-up).
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Measurement at three time points, baseline, 16 weeks and 6-month follow-up
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Adverse events
Time Frame: Through study completion, an average of 1 year
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Adverse events from training session and muscle biopsy sampling will be recorded
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Through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Truls Raastad, PhD, Norweigan School of Sport Sciences
- Principal Investigator: Karin Nordin, PhD, Uppsala University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01097
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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