Clinical trial · Interventional
Physical Training and Cancer-a Multicenter Clinical Trial
Physical Training and Cancer- Effects and Understanding of Mechanisms for Prevent and Minimizing Cancer Related Fatigue, Improve Quality of Life and Disease Outcome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral medicine strategies | Behavioral | — | UNRESOLVED |
| high intensity exercise | Behavioral | — | UNRESOLVED |
| low/medium intensity exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- High intensity
- description
- high intensity exercise 80-90%
- interventionNames
- Behavioral: high intensity exercise
- type
- EXPERIMENTAL
- label
- Low/Medium intensity
- description
- low/medium intensity exercise 40-50%
- interventionNames
- Behavioral: low/medium intensity exercise
- type
- EXPERIMENTAL
- label
- High Intensity with BM
- description
- high intensity exercise with Behavioral medicine strategies¨ 80-90%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (11)
- DERIVEDHenriksson 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. PMID 42097659
- DERIVEDMazzoni 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. PMID 37358262
- DERIVEDMazzoni 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. PMID 36738358
- DERIVEDHenriksson 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. PMID 36658635
- DERIVEDSchauer 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. PMID 36269530
- DERIVEDBrooke 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.