Breast Cancer FemalePhysCanNCT05218876
Effects of Moderate and High-intensity Exercise During Chemotherapy on Muscle Cells in Women With Breast Cancer
A study testing Low- to moderate intensity strength and endurance training and High intensity strength and endurance training in people with Breast Cancer Female, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
(Neo-)adjuvant chemotherapy for breast cancer has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side 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?
- Low- to moderate intensity strength and endurance training and High intensity strength and endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 8 Dec 2016to 30 Nov 2022
- 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
- diagnosed with stage I-III breast cancer
- 18 years old
- can understand and communicate in the Norwegian language
- scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of the 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 Moderate and High-Intensity Exercise During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer: a Randomized Controlled Trial
(Neo-)adjuvant chemotherapy for breast cancer has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high intensity training vs. low-to moderate intensity training on muscle tissue cellular outcomes and function in breast cancer patients during chemotherapy. The present study aims to compare the effects of high vs. low-to moderate intensity training on its ability to counteract deleterious effects of chemotherapy on skeletal muscle in women diagnosed with breast cancer. Eighty newly diagnosed women with breast cancer planned to start (neo-)adjuvant chemotherapy will be randomized to either a group performing a combination of strength and endurance training with high intensity or a group performing training with low to moderate intensity. Muscle biopsies from m. vastus lateralis for assessment of muscular cellular outcomes will be collected and muscle function and cardiorespiratory fitness will be measured before the first cycle of chemotherapy (or, when not possible, one week after) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% will be willing to take muscle biopsies. The study will give important information about the effects of different training intensities for breast cancer patients during treatment and will contribute with knowledge about how to refine exercise programs that are effective and compatible with multidisciplinary management of breast cancer.
Read the detailed description
The aim of this study is to investigate the effects high and low-to-moderate exercise intensity on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in breast cancer patients undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if treatment including taxane treatment have larger negative effect on muscle than taxane-free treatment.
Our hypotheses are:
- Both high-intensity and low to moderate intensity strength and endurance training during (neo-)adjuvant chemotherapy will reduce negative treatment effects on muscle fiber size, mitochondrial function, cellular stress, and thus reduce the negative effect on cardiorespiratory fitness and muscle function. High-intensity training will be superior to low to moderate-intensity training in counteracting the negative treatments effects.
- Both high-intensity and low to moderate intensity strength and endurance training during (neo-)adjuvant chemotherapy will increase muscle and blood levels of potential anti-tumor myokines.
- Treatment including taxane administration will have larger negative effect on muscle fiber size, mitochondrial function, cellular stress, and thus cardiorespiratory fitness and muscle function than taxane free treatment regardless of training intensity.
This study is a two-group randomized controlled trial. The participants will be randomly allocated into two training groups; one group performing the combination of strength and endurance training with high intensity and the other group performing the training with low to moderate intensity during (neo-) adjuvant treatment for breast cancer. Power calculations indicate that 20 participants are sufficient in each group for our primary outcome muscle fiber cross-sectional area. As we estimate that approximately 50% of the participants will be willing to take muscle biopsies a total of 80 participants will be recruited leading to a total of 40 participants with muscle biopsies.
Before the training period (T0) muscle biopsies, questionnaires and blood samples will be taken before the first chemotherapy cure. The first 2-4 weeks after cure 1 will be used as a familiarization period for tests and exercises, and to complete the remaining T0 tests. Testing will include measurements of physical capacity, body composition, and physical activity levels. All measurements are repeated halfway into the treatment (T1) and after the completion of treatment (T2). Training will start between cures 2 and 3 and will last throughout the treatment period, approximately 6 months.
The strength training consists of two supervised sessions per week and includes the following exercises: seated leg-press, chest-press, seated leg-curl, seated-row, leg-extension, and standing overhead-press using dumbbells. The low-to-moderate intensity group will perform 12 repetitions for 3 sets at 50% of 6RM load in the first weekly session and 20 repetitions for 3 sets at 50% of 10RM load in the second weekly session. The high intensity group will perform 6 repetitions for 3 sets at 6RM load in the first weekly session and 10 repetitions for 3 sets at 10RM load in the second weekly session.
The endurance exercise is home-based and followed up by a coach. The low-to-moderate intensity group do continuous-based exercise (running, cycling, walking uphill or any other endurance-based activity) in bouts of at least 10 min at an exercise intensity of 40-50% of the heart rate reserve. The exercise frequency is recommended to be 2-4 times a week with the main aim to reach 150 min of moderate intensity endurance exercise per week. The high intensity group conduct high-intensity interval exercise. The sessions will consist of two-minute exercise intervals (running, cycling, walking uphill or any other endurance-based activity) at an exercise intensity of 80-90% of the heart rate reserve (at the end of the 3rd session) with two minutes of rest between intervals. During the first week after familiarization, each session will consist of 6 intervals. Thereafter, one bout will be added every fourth week until 10 bouts per session are reached as the maximum, corresponding to 75 min of high intensity per week.
- Conditions
- Breast Cancer Female
- Being tested
- Low- to moderate intensity strength and endurance training, High intensity strength and endurance training
- Keywords
- Muscle fiber cross-sectional area, Muscle biopsies, Training, Oncology, Strength training, Endurance training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low- to moderate intensity strength and endurance trainingOther
Combination of strength and endurance training with low- to moderate intensity during chemotherapy
High intensity strength and endurance trainingOther
Combination of strength and endurance training with high intensity during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Low- to moderate intensity strength and endurance training | Experimental | Participants will perform a combination of strength and endurance training with low-to moderate-intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach. Receives: Other: Low- to moderate intensity strength and endurance training |
| High intensity strength and endurance training | Experimental | Participants will perform a combination of strength and endurance training with high intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach. Receives: Other: High intensity strength and endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fiber cross-sectional area
Change from baseline (T0) to end of intervention (end of training and treatment), approximately 6 months (T2) in muscle fiber cross-sectional area. This will be assessed by immunohistochemical staining of muscle fiber cross-sections for type 1 and type 2 muscle fibers and dystrophin (cell border).
Measured: From baseline (T0) to the 6 months time point (end of treatment and training, T2)
Secondary outcomes (12)
Muscle fiber cross-sectional area
Change from baseline (T0) to halfway into the intervention (halfway into training and treatment), approximately 3 months (T1) in muscle fiber cross-sectional area. This will be assessed by immunohistochemical staining of muscle fiber cross-sections for type 1 and type 2 muscle fibers and dystrophin (cell border).
Measured: From baseline (T0) to the 3 months time point (halfway into the treatment and training,T1)
Satellite cell content in muscle fiber cross-sections
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in satellite cell content in muscle fiber cross-sections. This will be assessed through immunohistochemical staining of satellite cells in muscle fiber cross-sections for type 1 and type 2 muscle fibers separately.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Myonuclei content in muscle fiber cross-sections
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in myonuclei content in muscle fiber cross-sections. This will be assessed through immunohistochemical staining of myonuclei in muscle fiber cross-sections for type 1 and type 2 muscle fibers separately.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
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 (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in protein levels of regulators of muscle fiber size (proteins involved in muscle protein synthesis and protein degradation [e.i. mTOR, MuRF, S6K1, p70S6k]). This will be assessed in muscle homogenate using Western blot analysis.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, αB-crystalline, Hsp 60 and Hsp 70)
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, αB-crystalline, Hsp 60 and Hsp 70). This will be assessed in muscle homogenate using Western blot analysis.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HADH)
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HADH). This will be assessed in muscle homogenate using Western blot analysis.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Myokines with potential anti-tumor effects
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in myokines with potential anti-tumor effects. This will be assessed in muscle homogenate using Western blot analysis.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Maximal muscle strength
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in maximal upper- and lower extremity muscle strength. This will be assessed as one repetition maximum in seated chest-press, seated single-leg press and knee extension.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Cardiorespiratory fitness
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in cardiorespiratory fitness. This will be assessed as maximal oxygen uptake during maximal walking/running until exhaustion on a treadmill.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Muscular endurance
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in muscular endurance. This will be assessed as the number of repetitions on 30% of one-repetition maximum in knee extension.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Fat free mass
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in fat free mass. This will be asses by dual dual energy X ray absorptiometry.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Fat mass
Change from baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2) in fat mass. This will be asses by dual dual energy X ray absorptiometry.
Measured: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start8 Dec 2016
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, University of Agder, Haukeland University Hospital, Uppsala University, Active against Cancer - Norway
- Responsible party
- Principal investigator, Truls Raastad, Norwegian School of Sport Sciences
- Investigators
- Truls Raastad, Professor, Principal investigator, Department of Physical Performance, Norwegian School of Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218876
- Sponsor's protocol ID
- PhysCan muskel
- Acronym
- PhysCan
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vikmoen O, Wiestad TH, Thormodsen I, Nordin K, Berntsen S, Demmelmaier I, Strandberg E, Raastad T. Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 11;11(11):e40811. doi: 10.2196/40811.
PubMed 36367769
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate and High-Intensity Exercise During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05218876
- Acronym / sponsor ID
- PhysCan / PhysCan muskel
- Conditions
- Breast Cancer Female
- Keywords
- Muscle fiber cross-sectional area, Muscle biopsies, Training, Oncology, Strength training, Endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, University of Agder, Haukeland University Hospital, Uppsala University, Active against Cancer - Norway
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Feb 2022 (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 has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high intensity training vs. low-to moderate intensity training on muscle tissue cellular outcomes and function in breast cancer patients during chemotherapy. The present study aims to compare the effects of high vs. low-to moderate intensity training on its ability to counteract deleterious effects of chemotherapy on skeletal muscle in women diagnosed with breast cancer. Eighty newly diagnosed women with breast cancer planned to start (neo-)adjuvant chemotherapy will be randomized to either a group performing a combination of strength and endurance training with high intensity or a group performing training with low to moderate intensity. Muscle biopsies from m. vastus lateralis for assessment of muscular cellular outcomes will be collected and muscle function and cardiorespiratory fitness will be measured before the first cycle of chemotherapy (or, when not possible, one week after) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% will be willing to take muscle biopsies. The study will give important information about the effects of different training intensities for breast cancer patients during treatment and will contribute with knowledge about how to refine exercise programs that are effective and compatible with multidisciplinary management of breast cancer.
Detailed description
The aim of this study is to investigate the effects high and low-to-moderate exercise intensity on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in breast cancer patients undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if treatment including taxane treatment have larger negative effect on muscle than taxane-free treatment.
Our hypotheses are:
- Both high-intensity and low to moderate intensity strength and endurance training during (neo-)adjuvant chemotherapy will reduce negative treatment effects on muscle fiber size, mitochondrial function, cellular stress, and thus reduce the negative effect on cardiorespiratory fitness and muscle function. High-intensity training will be superior to low to moderate-intensity training in counteracting the negative treatments effects.
- Both high-intensity and low to moderate intensity strength and endurance training during (neo-)adjuvant chemotherapy will increase muscle and blood levels of potential anti-tumor myokines.
- Treatment including taxane administration will have larger negative effect on muscle fiber size, mitochondrial function, cellular stress, and thus cardiorespiratory fitness and muscle function than taxane free treatment regardless of training intensity.
This study is a two-group randomized controlled trial. The participants will be randomly allocated into two training groups; one group performing the combination of strength and endurance training with high intensity and the other group performing the training with low to moderate intensity during (neo-) adjuvant treatment for breast cancer. Power calculations indicate that 20 participants are sufficient in each group for our primary outcome muscle fiber cross-sectional area. As we estimate that approximately 50% of the participants will be willing to take muscle biopsies a total of 80 participants will be recruited leading to a total of 40 participants with muscle biopsies.
Before the training period (T0) muscle biopsies, questionnaires and blood samples will be taken before the first chemotherapy cure. The first 2-4 weeks after cure 1 will be used as a familiarization period for tests and exercises, and to complete the remaining T0 tests. Testing will include measurements of physical capacity, body composition, and physical activity levels. All measurements are repeated halfway into the treatment (T1) and after the completion of treatment (T2). Training will start between cures 2 and 3 and will last throughout the treatment period, approximately 6 months.
The strength training consists of two supervised sessions per week and includes the following exercises: seated leg-press, chest-press, seated leg-curl, seated-row, leg-extension, and standing overhead-press using dumbbells. The low-to-moderate intensity group will perform 12 repetitions for 3 sets at 50% of 6RM load in the first weekly session and 20 repetitions for 3 sets at 50% of 10RM load in the second weekly session. The high intensity group will perform 6 repetitions for 3 sets at 6RM load in the first weekly session and 10 repetitions for 3 sets at 10RM load in the second weekly session.
The endurance exercise is home-based and followed up by a coach. The low-to-moderate intensity group do continuous-based exercise (running, cycling, walking uphill or any other endurance-based activity) in bouts of at least 10 min at an exercise intensity of 40-50% of the heart rate reserve. The exercise frequency is recommended to be 2-4 times a week with the main aim to reach 150 min of moderate intensity endurance exercise per week. The high intensity group conduct high-intensity interval exercise. The sessions will consist of two-minute exercise intervals (running, cycling, walking uphill or any other endurance-based activity) at an exercise intensity of 80-90% of the heart rate reserve (at the end of the 3rd session) with two minutes of rest between intervals. During the first week after familiarization, each session will consist of 6 intervals. Thereafter, one bout will be added every fourth week until 10 bouts per session are reached as the maximum, corresponding to 75 min of high intensity per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low- to moderate intensity strength and endurance training | Experimental | Other: Low- to moderate intensity strength and endurance trainingParticipants will perform a combination of strength and endurance training with low-to moderate-intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach. |
| High intensity strength and endurance training | Experimental | Other: High intensity strength and endurance trainingParticipants will perform a combination of strength and endurance training with high intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with stage I-III breast cancer
- 18 years old
- can understand and communicate in the Norwegian language
- scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of the 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 |
|---|---|---|
| Low- to moderate intensity strength and endurance trainingCombination of strength and endurance training with low- to moderate intensity during chemotherapy | Other | Low- to moderate intensity strength and endurance training |
| High intensity strength and endurance trainingCombination of strength and endurance training with high intensity during chemotherapy | Other | High intensity strength and endurance training |
Primary outcome
Muscle fiber cross-sectional area
Time frame: From baseline (T0) to the 6 months time point (end of treatment and training, T2)
Change from baseline (T0) to end of intervention (end of training and treatment), approximately 6 months (T2) in muscle fiber cross-sectional area. This will be assessed by immunohistochemical staining of muscle fiber cross-sections for type 1 and type 2 muscle fibers and dystrophin (cell border).
12 secondary outcomes
Muscle fiber cross-sectional area
Time frame: From baseline (T0) to the 3 months time point (halfway into the treatment and training,T1)
Satellite cell content in muscle fiber cross-sections
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Myonuclei content in muscle fiber cross-sections
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
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 (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
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 (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HADH)
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Myokines with potential anti-tumor effects
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Maximal muscle strength
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Cardiorespiratory fitness
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Muscular endurance
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Fat free mass
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Fat mass
Time frame: From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 36367769Vikmoen O, Wiestad TH, Thormodsen I, Nordin K, Berntsen S, Demmelmaier I, Strandberg E, Raastad T. Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 11;11(11):e40811. doi: 10.2196/40811.
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Department of Physical Performance, Norwegian School of Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low- to moderate intensity strength and endurance training and High intensity strength and endurance training in people with Breast Cancer Female, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 4 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: finished, as of the sponsor's last update on 28 Nov 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle fiber cross-sectional area (time frame: From baseline (T0) to the 6 months time point (end of treatment and training, T2)). 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 NCT05218876, which also lists 1 linked publication.
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 28 Nov 2023.