Breast CancerPhys-CanNCT02473003
Physical Training and Cancer-a Multicenter Clinical Trial
A study testing high intensity exercise, low/medium intensity exercise and Behavioral medicine strategies in people with Breast Cancer and Colorectal Cancer, run by Uppsala University.
Trial summary
Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality of life negatively. There is limited knowledge about the physical mechanisms that cause fatigue, and there is no medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- high intensity exercise, low/medium intensity exercise and Behavioral medicine strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- understand and talk Swedish.
- patients with breast cancer who receive neoadjuvant / adjuvant chemotherapy and / or adjuvant radiotherapy and / or adjuvant endocrine treatment.
- patients with colorectal cancer who receive adjuvant chemotherapy.
- patients with prostate cancer who receive neoadjuvant / adjuvant endocrine treatment with the addition of curative radiation therapy.
Who cannot join
- Patients unable to perform basic activities of daily living.
- Patients with cognitive disorders such as dementia and severe psychiatric illness.
- Patients with disabilities that may prevent physical activity: (eg, unstable angina, heart failure, chronic obstructive pulmonary disease, orthopedic and neurological diseases).
- Breast cancer stage IIIb.
- Undergoing treatment for other types of malignant disease.
About this study
Official title: Physical Training and Cancer- Effects and Understanding of Mechanisms for Prevent and Minimizing Cancer Related Fatigue, Improve Quality of Life and Disease Outcome
Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality of life negatively. There is limited knowledge about the physical mechanisms that cause fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience, but the investigators need to learn more about the type and intensity of exercise that works the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM) intensity physical training, with or without behavioural medicine (BM) support strategies, during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL), mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return to a daily life after completed treatment and return to work. The investigators will also describe changes in inflammatory markers and cytokines related to physical training and gene expressions following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used, 600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per week during 6 months. This project will give; new knowledge about aspects for individuals to gain improved well-being and quality of life, facilitated return to work, and possibly reduced risk of cancer recurrence. This in turn would result in lower burden on the health care system, reduced societal costs and have a positive impact on public health. Implementation of the results into clinical practice will be facilitated by the close collaboration between researchers and clinicians, and the fact that the study is performed in clinical settings.
Read the detailed description
Purpose and Aims The main aim is to determine the effects of high or low intensity physical training with or without integrated behavioral medicine support strategies to prevent and minimize cancer related fatigue (CRF), improve health related quality of life (QoL) and to understand the role of inflammation and cytokines in the development and maintenance of CRF, as well as to increase knowledge with respect to cost-effectiveness of rehabilitation programs. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centers in Sweden; Uppsala, Lund/Malmö and Linköping and one in Norway.
More specifically, the investigators' objectives are to:
- Investigate the effects of high intensity training compared to low intensity training on patient reported outcomes (CRF as primary endpoint), chemotherapy/radiation completion rates, medical (oncology) adverse effects, physical activity and daily function, during adjuvant treatment and at long-term-follow up. In addition, effects on the course of disease (e.g time to relapse).
- Investigate if supplemental behavioural medicine support strategies increase adherence to exercise during adjuvant therapy and further if they increase the maintenance of physical activity behaviours and decrease sedentary time in the long run.
- Explore the role of changes in inflammatory markers and cytokines related to physical training and following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL.
- Pursue the investigation of a direct role of cytokines secreted from the working muscles, in inhibiting cancer cell growth and inducing apoptosis.
- Evaluate health economic issues; cost effectiveness of the interventions, health production and individual wellbeing.
In Phys-Can, the investigators will implement rigorously designed and adequately powered randomized longitudinal multicenter clinical trials, with physical training and behavioral medicine support interventions. The highly multi- and interdisciplinary and international consortium behind this proposal is in an excellent position to perform international and interdisciplinary competence- and network-building activities to generate valid, high quality data covering all areas included in the project, from basic biomedical data to patient reported outcomes (PROs), i.e. from bench to bedside. This is unique in health care sciences.
Study design A 2x2 factorial design will be used. With this design the investigators can study main effects and interactions between factors (groups). Patients will be randomized to one of the following groups; A) individually tailored high intensity training twice a week with (H+BM) or without behavioral medicine support strategies (H) or B) individually tailored low intensity training twice a week with (L+BM) or without behavioral medicine support strategies (L).
Study sample/procedure Patients, who are recently diagnosed with breast cancer, colorectal cancer or prostate cancer and scheduled for adjuvant therapy at Uppsala, Lund/Malmö, Linköping and Haukeland University hospitals will be consecutively included in the study. Based on the power calculation, 612 patients will be included.
All patients will exercise twice a week during 6 months which is equal to the most extensive adjuvant treatment period. It is also an optimal period to achieve physical training effects and to establish physical activity behavior. Physical training under the guidance of trained coaches will be offered twice a week. Training intensity is 40-50% (low intensity group) or 80-90% (high intensity group) of maximal cardiorespiratory fitness/muscular strength. Physical training sessions consist of both cardiorespiratory and resistance exercise. Every four week, progress from resistance training is evaluated by means of a strength test, and absolute intensity is adjusted accordingly Motivational and self-regulatory behavioral medicine support strategies (motivational and self-regulatory strategies) will be provided for the H+BM and the L+BM groups i.e. strategies to enhance engagement in the high and low intensity exercise programs respectively, and to maintain health enhancing physical activity after the completion of the programs.
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- high intensity exercise, low/medium intensity exercise, Behavioral medicine strategies
- Keywords
- Breast cancer, prostate cancer, colorectal cancer, fatigue, physical exercise, randomised trial, intervention
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity exerciseBehavioural
high intensity exercise 80-90%
low/medium intensity exerciseBehavioural
low/medium intensity exercise 40-50%
Behavioral medicine strategiesBehavioural
Motivational and self-regulatory behavioral medicine support strategies
| Study group | Role | What they receive |
|---|---|---|
| High intensity | Experimental | high intensity exercise 80-90% Receives: Behavioral: high intensity exercise |
| Low/Medium intensity | Experimental | low/medium intensity exercise 40-50% Receives: Behavioral: low/medium intensity exercise |
| High Intensity with BM | Experimental | high intensity exercise with Behavioral medicine strategies¨ 80-90% Receives: Behavioral: high intensity exercise; Behavioral: Behavioral medicine strategies |
| Low/Medium intensity with BM | Experimental | low/medium intensity exercise with Behavioral medicine strategies 40-50% Receives: Behavioral: low/medium intensity exercise; Behavioral: Behavioral medicine strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue
Multi Dimensional Fatigue Inventory (MFI),
Measured: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Secondary outcomes (12)
Change in Quality of Life
The European Organisation for Research and Treatment of Cancer (EORTC)EORTC-QLQ30
Measured: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Mood disturbance
Hospital Anxiety and Depression Scale- (HADs)
Measured: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Function in Daily life
WHO Disability Assessment Schedule
Measured: 6 months,1, 2, 5 years
Change in pain
Brief Pain Inventory
Measured: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Cardio respiratory fitness
maximal oxygen uptake (VO2 max test)
Measured: 6 month
Change in Muscle strength
One Repetition Maximum Lower extremities: One Repetition Maximum (leg press)
Measured: 6 months
Health Economy
Euroqol- (EQ5D)
Measured: 12 months
Cancer recurrence
number of patients with recurrence
Measured: 10 year
Sleep
Insomnia severe index
Measured: 6 months
Health Economy register
register data
Measured: 12 months
Cancer recurrence
Medical records
Measured: 6 months, 1, 2, 5, 10 years
Treatment completion rate
Medical records
Measured: 1, 2, 5, 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, Linkoeping University, Lund University, University of Agder, Copenhagen University Hospital, Denmark, Norwegian School of Sport Sciences, Amsterdam UMC, location VUmc, University of Amsterdam, University of Leeds
- Responsible party
- Principal investigator, Karin Nordin, Uppsala University
- Investigators
- Karin Nordin, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473003
- Sponsor's protocol ID
- D0273401, CAN2012/631,621
- Acronym
- Phys-Can
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2014
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Henriksson A, Stenling A, Mazzoni AS, Sjovall K, Borjeson S, Berntsen S, Bean CG, Buffart LM, Nordin K, Demmelmaier I. What is the adherence to an exercise intervention during (neo-)adjuvant chemotherapy among Swedish patients with breast cancer? Data from the Phys-Can randomised controlled trial. BMJ Open. 2026 May 7;16(5):e105540. doi: 10.1136/bmjopen-2025-105540.
PubMed 42097659Mazzoni AS, Helgesen Bjorke AC, Stenling A, Borjeson S, Sjovall K, Berntsen S, Demmelmaier I, Nordin K. The Role of Long-Term Physical Activity in Relation to Cancer-Related Health Outcomes: A 12-Month Follow-up of the Phys-Can RCT. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231178869. doi: 10.1177/15347354231178869.
PubMed 37358262Mazzoni 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 36738358Henriksson A, Strandberg E, Stenling A, Mazzoni AS, Sjovall K, Borjeson S, Raastad T, Demmelmaier I, Berntsen S, Nordin K. Does inflammation markers or treatment type moderate exercise intensity effects on changes in muscle strength in cancer survivors participating in a 6-month combined resistance- and endurance exercise program? Results from the Phys-Can trial. BMC Sports Sci Med Rehabil. 2023 Jan 19;15(1):8. doi: 10.1186/s13102-023-00617-3.
PubMed 36658635Schauer T, Henriksson A, Strandberg E, Lindman H, Berntsen S, Demmelmaier I, Raastad T, Nordin K, Christensen JF. Pre-treatment levels of inflammatory markers and chemotherapy completion rates in patients with early-stage breast cancer. Int J Clin Oncol. 2023 Jan;28(1):89-98. doi: 10.1007/s10147-022-02255-0. Epub 2022 Oct 21.
PubMed 36269530Brooke HL, Mazzoni AS, Buffart LM, Berntsen S, Nordin K, Demmelmaier I. Patterns and determinants of adherence to resistance and endurance training during cancer treatment in the Phys-Can RCT. BMC Sports Sci Med Rehabil. 2022 Aug 13;14(1):155. doi: 10.1186/s13102-022-00548-5.
PubMed 35964124Mazzoni AS, Brooke HL, Berntsen S, Nordin K, Demmelmaier I. Effect of self-regulatory behaviour change techniques and predictors of physical activity maintenance in cancer survivors: a 12-month follow-up of the Phys-Can RCT. BMC Cancer. 2021 Nov 25;21(1):1272. doi: 10.1186/s12885-021-08996-x.
PubMed 34823494Schauer T, Mazzoni AS, Henriksson A, Demmelmaier I, Berntsen S, Raastad T, Nordin K, Pedersen BK, Christensen JF. Exercise intensity and markers of inflammation during and after (neo-) adjuvant cancer treatment. Endocr Relat Cancer. 2021 Mar;28(3):191-201. doi: 10.1530/ERC-20-0507.
PubMed 33608485Mazzoni AS, Brooke HL, Berntsen S, Nordin K, Demmelmaier I. Exercise Adherence and Effect of Self-Regulatory Behavior Change Techniques in Patients Undergoing Curative Cancer Treatment: Secondary Analysis from the Phys-Can Randomized Controlled Trial. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420946834. doi: 10.1177/1534735420946834.
PubMed 32909467Johnsson A, Demmelmaier I, Sjovall K, Wagner P, Olsson H, Tornberg AB. A single exercise session improves side-effects of chemotherapy in women with breast cancer: an observational study. BMC Cancer. 2019 Nov 8;19(1):1073. doi: 10.1186/s12885-019-6310-0.
PubMed 31703567Berntsen S, Aaronson NK, Buffart L, Borjeson S, Demmelmaier I, Hellbom M, Hojman P, Igelstrom H, Johansson B, Pingel R, Raastad T, Velikova G, Asenlof P, Nordin K. Design of a randomized controlled trial of physical training and cancer (Phys-Can) - the impact of exercise intensity on cancer related fatigue, quality of life and disease outcome. BMC Cancer. 2017 Mar 27;17(1):218. doi: 10.1186/s12885-017-3197-5.
PubMed 28347291
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training and Cancer- Effects and Understanding of Mechanisms for Prevent and Minimizing Cancer Related Fatigue, Improve Quality of Life and Disease Outcome
- ClinicalTrials.gov ID
- NCT02473003
- Acronym / sponsor ID
- Phys-Can / D0273401, CAN2012/631,621
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Keywords
- Breast cancer, prostate cancer, colorectal cancer, fatigue, physical exercise, randomised trial, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, Linkoeping University, Lund University, University of Agder, Copenhagen University Hospital, Denmark, Norwegian School of Sport Sciences, Amsterdam UMC, location VUmc, University of Amsterdam, University of Leeds
- Study start
- Mar 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jun 2015 (estimated)
- 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.
Excessive tiredness (fatigue) is a common problem in cancer patients and can affect quality of life negatively. There is limited knowledge about the physical mechanisms that cause fatigue, and there is no medical treatment. Physical activity can reduce the inconvenience, but the investigators need to learn more about the type and intensity of exercise that works the best as well as how to motivate patients to exercise. The overall aim, is to evaluate the efficacy and cost-effectiveness of individually tailored high (H) and low/medium (LM) intensity physical training, with or without behavioural medicine (BM) support strategies, during adjuvant oncological treatment on; Cancer Related Fatigue (CRF),Quality of Life (QoL), mood disturbance, adherence to the cancer treatment, adverse effects, disease outcome, return to a daily life after completed treatment and return to work. The investigators will also describe changes in inflammatory markers and cytokines related to physical training and gene expressions following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centres in Sweden; Uppsala, Lund/Malmö and Linköping. A 2x2 factorial design will be used, 600 patients will be randomised to H, H+BM, LM or LM+BM. Patients will train two times per week during 6 months. This project will give; new knowledge about aspects for individuals to gain improved well-being and quality of life, facilitated return to work, and possibly reduced risk of cancer recurrence. This in turn would result in lower burden on the health care system, reduced societal costs and have a positive impact on public health. Implementation of the results into clinical practice will be facilitated by the close collaboration between researchers and clinicians, and the fact that the study is performed in clinical settings.
Detailed description
Purpose and Aims The main aim is to determine the effects of high or low intensity physical training with or without integrated behavioral medicine support strategies to prevent and minimize cancer related fatigue (CRF), improve health related quality of life (QoL) and to understand the role of inflammation and cytokines in the development and maintenance of CRF, as well as to increase knowledge with respect to cost-effectiveness of rehabilitation programs. This will be evaluated in newly diagnosed breast, colorectal and prostate cancer patients during adjuvant therapy at three different centers in Sweden; Uppsala, Lund/Malmö and Linköping and one in Norway.
More specifically, the investigators' objectives are to:
- Investigate the effects of high intensity training compared to low intensity training on patient reported outcomes (CRF as primary endpoint), chemotherapy/radiation completion rates, medical (oncology) adverse effects, physical activity and daily function, during adjuvant treatment and at long-term-follow up. In addition, effects on the course of disease (e.g time to relapse).
- Investigate if supplemental behavioural medicine support strategies increase adherence to exercise during adjuvant therapy and further if they increase the maintenance of physical activity behaviours and decrease sedentary time in the long run.
- Explore the role of changes in inflammatory markers and cytokines related to physical training and following training to investigate whether these serve as mediators for the effects of physical training on CRF and QoL.
- Pursue the investigation of a direct role of cytokines secreted from the working muscles, in inhibiting cancer cell growth and inducing apoptosis.
- Evaluate health economic issues; cost effectiveness of the interventions, health production and individual wellbeing.
In Phys-Can, the investigators will implement rigorously designed and adequately powered randomized longitudinal multicenter clinical trials, with physical training and behavioral medicine support interventions. The highly multi- and interdisciplinary and international consortium behind this proposal is in an excellent position to perform international and interdisciplinary competence- and network-building activities to generate valid, high quality data covering all areas included in the project, from basic biomedical data to patient reported outcomes (PROs), i.e. from bench to bedside. This is unique in health care sciences.
Study design A 2x2 factorial design will be used. With this design the investigators can study main effects and interactions between factors (groups). Patients will be randomized to one of the following groups; A) individually tailored high intensity training twice a week with (H+BM) or without behavioral medicine support strategies (H) or B) individually tailored low intensity training twice a week with (L+BM) or without behavioral medicine support strategies (L).
Study sample/procedure Patients, who are recently diagnosed with breast cancer, colorectal cancer or prostate cancer and scheduled for adjuvant therapy at Uppsala, Lund/Malmö, Linköping and Haukeland University hospitals will be consecutively included in the study. Based on the power calculation, 612 patients will be included.
All patients will exercise twice a week during 6 months which is equal to the most extensive adjuvant treatment period. It is also an optimal period to achieve physical training effects and to establish physical activity behavior. Physical training under the guidance of trained coaches will be offered twice a week. Training intensity is 40-50% (low intensity group) or 80-90% (high intensity group) of maximal cardiorespiratory fitness/muscular strength. Physical training sessions consist of both cardiorespiratory and resistance exercise. Every four week, progress from resistance training is evaluated by means of a strength test, and absolute intensity is adjusted accordingly Motivational and self-regulatory behavioral medicine support strategies (motivational and self-regulatory strategies) will be provided for the H+BM and the L+BM groups i.e. strategies to enhance engagement in the high and low intensity exercise programs respectively, and to maintain health enhancing physical activity after the completion of the programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity | Experimental | Behavioral: high intensity exercisehigh intensity exercise 80-90% |
| Low/Medium intensity | Experimental | Behavioral: low/medium intensity exerciselow/medium intensity exercise 40-50% |
| High Intensity with BM | Experimental | Behavioral: high intensity exercise, Behavioral: Behavioral medicine strategieshigh intensity exercise with Behavioral medicine strategies¨ 80-90% |
| Low/Medium intensity with BM | Experimental | Behavioral: low/medium intensity exercise, Behavioral: Behavioral medicine strategieslow/medium intensity exercise with Behavioral medicine strategies 40-50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- understand and talk Swedish.
- patients with breast cancer who receive neoadjuvant / adjuvant chemotherapy and / or adjuvant radiotherapy and / or adjuvant endocrine treatment.
- patients with colorectal cancer who receive adjuvant chemotherapy.
- patients with prostate cancer who receive neoadjuvant / adjuvant endocrine treatment with the addition of curative radiation therapy.
Key exclusion criteria (5 listed)
- Patients unable to perform basic activities of daily living.
- Patients with cognitive disorders such as dementia and severe psychiatric illness.
- Patients with disabilities that may prevent physical activity: (eg, unstable angina, heart failure, chronic obstructive pulmonary disease, orthopedic and neurological diseases).
- Breast cancer stage IIIb.
- Undergoing treatment for other types of malignant disease.
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 |
|---|---|---|
| high intensity exercisehigh intensity exercise 80-90% | Behavioural | High Intensity with BM, High intensity |
| low/medium intensity exerciselow/medium intensity exercise 40-50% | Behavioural | Low/Medium intensity, Low/Medium intensity with BM |
| Behavioral medicine strategiesMotivational and self-regulatory behavioral medicine support strategies | Behavioural | High Intensity with BM, Low/Medium intensity with BM |
Primary outcome
Change in Fatigue
Time frame: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Multi Dimensional Fatigue Inventory (MFI),
12 secondary outcomes
Change in Quality of Life
Time frame: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Mood disturbance
Time frame: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Function in Daily life
Time frame: 6 months,1, 2, 5 years
Change in pain
Time frame: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years
Change in Cardio respiratory fitness
Time frame: 6 month
Change in Muscle strength
Time frame: 6 months
Health Economy
Time frame: 12 months
Cancer recurrence
Time frame: 10 year
Sleep
Time frame: 6 months
Health Economy register
Time frame: 12 months
Cancer recurrence
Time frame: 6 months, 1, 2, 5, 10 years
Treatment completion rate
Time frame: 1, 2, 5, 10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 42097659Henriksson A, Stenling A, Mazzoni AS, Sjovall K, Borjeson S, Berntsen S, Bean CG, Buffart LM, Nordin K, Demmelmaier I. What is the adherence to an exercise intervention during (neo-)adjuvant chemotherapy among Swedish patients with breast cancer? Data from the Phys-Can randomised controlled trial. BMJ Open. 2026 May 7;16(5):e105540. doi: 10.1136/bmjopen-2025-105540.
- Derived from this study: PubMed 37358262Mazzoni AS, Helgesen Bjorke AC, Stenling A, Borjeson S, Sjovall K, Berntsen S, Demmelmaier I, Nordin K. The Role of Long-Term Physical Activity in Relation to Cancer-Related Health Outcomes: A 12-Month Follow-up of the Phys-Can RCT. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231178869. doi: 10.1177/15347354231178869.
- 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 36658635Henriksson A, Strandberg E, Stenling A, Mazzoni AS, Sjovall K, Borjeson S, Raastad T, Demmelmaier I, Berntsen S, Nordin K. Does inflammation markers or treatment type moderate exercise intensity effects on changes in muscle strength in cancer survivors participating in a 6-month combined resistance- and endurance exercise program? Results from the Phys-Can trial. BMC Sports Sci Med Rehabil. 2023 Jan 19;15(1):8. doi: 10.1186/s13102-023-00617-3.
- Derived from this study: PubMed 36269530Schauer T, Henriksson A, Strandberg E, Lindman H, Berntsen S, Demmelmaier I, Raastad T, Nordin K, Christensen JF. Pre-treatment levels of inflammatory markers and chemotherapy completion rates in patients with early-stage breast cancer. Int J Clin Oncol. 2023 Jan;28(1):89-98. doi: 10.1007/s10147-022-02255-0. Epub 2022 Oct 21.
- Derived from this study: PubMed 35964124Brooke HL, Mazzoni AS, Buffart LM, Berntsen S, Nordin K, Demmelmaier I. Patterns and determinants of adherence to resistance and endurance training during cancer treatment in the Phys-Can RCT. BMC Sports Sci Med Rehabil. 2022 Aug 13;14(1):155. doi: 10.1186/s13102-022-00548-5.
- Derived from this study: PubMed 34823494Mazzoni AS, Brooke HL, Berntsen S, Nordin K, Demmelmaier I. Effect of self-regulatory behaviour change techniques and predictors of physical activity maintenance in cancer survivors: a 12-month follow-up of the Phys-Can RCT. BMC Cancer. 2021 Nov 25;21(1):1272. doi: 10.1186/s12885-021-08996-x.
- Derived from this study: PubMed 33608485Schauer T, Mazzoni AS, Henriksson A, Demmelmaier I, Berntsen S, Raastad T, Nordin K, Pedersen BK, Christensen JF. Exercise intensity and markers of inflammation during and after (neo-) adjuvant cancer treatment. Endocr Relat Cancer. 2021 Mar;28(3):191-201. doi: 10.1530/ERC-20-0507.
- Derived from this study: PubMed 32909467Mazzoni AS, Brooke HL, Berntsen S, Nordin K, Demmelmaier I. Exercise Adherence and Effect of Self-Regulatory Behavior Change Techniques in Patients Undergoing Curative Cancer Treatment: Secondary Analysis from the Phys-Can Randomized Controlled Trial. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420946834. doi: 10.1177/1534735420946834.
- Derived from this study: PubMed 31703567Johnsson A, Demmelmaier I, Sjovall K, Wagner P, Olsson H, Tornberg AB. A single exercise session improves side-effects of chemotherapy in women with breast cancer: an observational study. BMC Cancer. 2019 Nov 8;19(1):1073. doi: 10.1186/s12885-019-6310-0.
- Derived from this study: PubMed 28347291Berntsen S, Aaronson NK, Buffart L, Borjeson S, Demmelmaier I, Hellbom M, Hojman P, Igelstrom H, Johansson B, Pingel R, Raastad T, Velikova G, Asenlof P, Nordin K. Design of a randomized controlled trial of physical training and cancer (Phys-Can) - the impact of exercise intensity on cancer related fatigue, quality of life and disease outcome. BMC Cancer. 2017 Mar 27;17(1):218. doi: 10.1186/s12885-017-3197-5.
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Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Karin Nordin, Professor principal investigator
Uppsala University
Questions about this trial
What is this clinical trial studying?
A study testing high intensity exercise, low/medium intensity exercise and Behavioral medicine strategies in people with Breast Cancer and Colorectal Cancer, run by Uppsala University.
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 5 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Fatigue (time frame: post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years). 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 NCT02473003, which also lists 11 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 21 Dec 2023.