Physical Training and Cancer-a Multicenter Clinical Trial

NCT02473003 | Unknown

• 1 other identifier: D0273401, CAN2012/631,621
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Breast Cancer; Colorectal Cancer; Prostate Cancer

Keywords

Breast cancer; prostate cancer; colorectal cancer; fatigue; physical exercise; randomised trial; intervention

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue

  Multi Dimensional Fatigue Inventory (MFI),

  post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years

Secondary Outcomes (12)

• Change in Quality of Life

  post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years

• Change in Mood disturbance

  post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years

• Change in Function in Daily life

  6 months,1, 2, 5 years

• Change in pain

  post oncol treatment (expected time frame 6-8 weeks), 6 month, 1,2,5 years

• Change in Cardio respiratory fitness

  6 month

Study Arms (4)

High intensity

EXPERIMENTAL

high intensity exercise 80-90%

Behavioral: high intensity exercise

Low/Medium intensity

EXPERIMENTAL

low/medium intensity exercise 40-50%

Behavioral: low/medium intensity exercise

High Intensity with BM

EXPERIMENTAL

high intensity exercise with Behavioral medicine strategies¨ 80-90%

Behavioral: high intensity exercise; Behavioral: Behavioral medicine strategies

Low/Medium intensity with BM

EXPERIMENTAL

low/medium intensity exercise with Behavioral medicine strategies 40-50%

Behavioral: low/medium intensity exercise; Behavioral: Behavioral medicine strategies

Interventions

high intensity exercise BEHAVIORAL

high intensity exercise 80-90%

High Intensity with BM; High intensity

low/medium intensity exercise BEHAVIORAL

low/medium intensity exercise 40-50%

Low/Medium intensity; Low/Medium intensity with BM

Behavioral medicine strategies BEHAVIORAL

Motivational and self-regulatory behavioral medicine support strategies

High Intensity with BM; Low/Medium intensity with BM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator
• Swedish Cancer Society: collaborator
• Nordic Cancer Union: collaborator
• Linkoeping University: collaborator
• Lund University: collaborator
• University of Agder: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Norwegian School of Sport Sciences: collaborator
• Amsterdam UMC, location VUmc: collaborator
• University of Amsterdam: collaborator
• University of Leeds: collaborator

Related Publications (10)

• Mazzoni 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 DERIVED

• Mazzoni 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 DERIVED

• Henriksson 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 DERIVED

• Schauer 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 DERIVED

• Brooke 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.

  PMID: 35964124 DERIVED

• Mazzoni 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.

  PMID: 34823494 DERIVED

• Schauer 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.

  PMID: 33608485 DERIVED

• Mazzoni 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.

  PMID: 32909467 DERIVED

• Johnsson 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.

  PMID: 31703567 DERIVED

• Berntsen 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.

  PMID: 28347291 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Fatigue; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karin Nordin, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: June 16, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 21, 2023

Record last verified: 2023-12