Breast Cancer FemaleNCT04586517
Effect of Heavy-load Resistance Training During Chemotherapy on Muscle Cellular Outcomes
A study testing Heavy-load resistance training in people with Breast Cancer Female, run by Uppsala University at 1 site in Sweden.
Trial summary
(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Heavy-load resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 5 Dec 2018to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Heavy-load Resistance Training During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer
(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. 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. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Heavy-load resistance training, Control
- Keywords
- Breast cancer, Resistance training, Chemotherapy, Randomized controlled trial, Muscle biopsies, Cross-sectional fiber area
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy-load resistance trainingOther
Also called Physical exercise, Physical training
Supervised heavy-load resistance training during chemotherapy treatment
ControlOther
Also called usual care
Activity as usual during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Heavy-load resistance training |
| Control group | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in muscle fiber cross-sectional area
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
Measured: From baseline to the 16 week time-point
Secondary outcomes (9)
Assessment of changes in muscle fiber cross-sectional area
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
Measured: From baseline to 6-month follow-up
Assessment of changes in satellite cell content in muscle fiber cross-sections
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
Measured: From baseline to the 16 week time-point and from baseline to 6-month follow-up
Assessment of changes in myonuclei content in muscle fiber cross-sections
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
Measured: From baseline to the 16 week time-point and from baseline to 6-month follow-up
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)
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
Measured: From baseline to the 16 week time-point and from baseline to 6-month follow-up
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)
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
Measured: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Assessment of changes in protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HAD)
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
Measured: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Assessment of changes in myokines with potential anti-tumor effects
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
Measured: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Changes in muscle strength
Maximal upper- and lower extremity muscle strength will be assessed as one repetition maximum in seated chest-press and seated single-leg press
Measured: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Cardiorespiratory fitness
Cardiorespiratory fitness will be assessed as maximal oxygen uptake during maximal walking/running until exhaustion on a treadmill
Measured: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Dec 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Society, Norwegian Cancer Society, Norwegian School of Sport Sciences, University of Agder, Copenhagen University Hospital, Rigshospitalet, Uppsala University Hospital
- Responsible party
- Principal investigator, Karin Nordin, Uppsala University
- Investigators
- Truls Raastad, PhD, Principal investigator, Norweigan School of Sport SciencesKarin Nordin, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586517
- Sponsor's protocol ID
- 2020-01097
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Vikmoen O, Strandberg E, Svindland KV, Henriksson A, Mazzoni AS, Johansson B, Jonsson J, Karakatsanis A, Anneback M, Kudren D, Lindman H, Warnberg F, Berntsen S, Demmelmaier I, Nordin K, Raastad T. Effects of heavy-load strength training during (neo-)adjuvant chemotherapy on muscle strength, muscle fiber size, myonuclei, and satellite cells in women with breast cancer. FASEB J. 2024 Jul 15;38(13):e23784. doi: 10.1096/fj.202400634R.
PubMed 38953567Mazzoni AS, Strandberg E, Borjeson S, Sjovall K, Berntsen S, Demmelmaier I, Nordin K. Reallocating sedentary time to physical activity: effects on fatigue and quality of life in patients with breast cancer in the Phys-Can project. Support Care Cancer. 2023 Feb 4;31(2):151. doi: 10.1007/s00520-023-07614-9.
PubMed 36738358Strandberg E, Vassbakk-Svindland K, Henriksson A, Johansson B, Vikmoen O, Kudren D, Schauer T, Lindman H, Warnberg F, Berntsen S, Demmelmaier I, Nordin K, Raastad T. Effects of heavy-load resistance training during (neo-)adjuvant chemotherapy on muscle cellular outcomes in women with breast cancer. Medicine (Baltimore). 2021 Mar 12;100(10):e24960. doi: 10.1097/MD.0000000000024960.
PubMed 33725859
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heavy-load Resistance Training During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04586517
- Acronym / sponsor ID
- 2020-01097
- Conditions
- Breast Cancer Female
- Keywords
- Breast cancer, Resistance training, Chemotherapy, Randomized controlled trial, Muscle biopsies, Cross-sectional fiber area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Cancer Society, Norwegian Cancer Society, Norwegian School of Sport Sciences, University of Agder, Copenhagen University Hospital, Rigshospitalet, Uppsala University Hospital
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. 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. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Heavy-load resistance trainingParticipants 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. |
| Control group | Active comparator | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy-load resistance trainingAlso: Physical exercise, Physical trainingSupervised heavy-load resistance training during chemotherapy treatment | Other | Intervention group |
| ControlAlso: usual careActivity as usual during chemotherapy | Other | Control group |
Primary outcome
Assessment of changes in muscle fiber cross-sectional area
Time frame: From baseline to the 16 week time-point
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
9 secondary outcomes
Assessment of changes in muscle fiber cross-sectional area
Time frame: From baseline to 6-month follow-up
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
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
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
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
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
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
Changes in muscle strength
Time frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Cardiorespiratory fitness
Time frame: From baseline to the 16 week time-point and from baseline to the 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 38953567Vikmoen O, Strandberg E, Svindland KV, Henriksson A, Mazzoni AS, Johansson B, Jonsson J, Karakatsanis A, Anneback M, Kudren D, Lindman H, Warnberg F, Berntsen S, Demmelmaier I, Nordin K, Raastad T. Effects of heavy-load strength training during (neo-)adjuvant chemotherapy on muscle strength, muscle fiber size, myonuclei, and satellite cells in women with breast cancer. FASEB J. 2024 Jul 15;38(13):e23784. doi: 10.1096/fj.202400634R.
- Derived from this study: PubMed 36738358Mazzoni AS, Strandberg E, Borjeson S, Sjovall K, Berntsen S, Demmelmaier I, Nordin K. Reallocating sedentary time to physical activity: effects on fatigue and quality of life in patients with breast cancer in the Phys-Can project. Support Care Cancer. 2023 Feb 4;31(2):151. doi: 10.1007/s00520-023-07614-9.
- Derived from this study: PubMed 33725859Strandberg E, Vassbakk-Svindland K, Henriksson A, Johansson B, Vikmoen O, Kudren D, Schauer T, Lindman H, Warnberg F, Berntsen S, Demmelmaier I, Nordin K, Raastad T. Effects of heavy-load resistance training during (neo-)adjuvant chemotherapy on muscle cellular outcomes in women with breast cancer. Medicine (Baltimore). 2021 Mar 12;100(10):e24960. doi: 10.1097/MD.0000000000024960.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truls Raastad, PhD principal investigator
Norweigan School of Sport Sciences
Karin Nordin, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy-load resistance training in people with Breast Cancer Female, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in muscle fiber cross-sectional area (time frame: From baseline to the 16 week time-point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586517, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.