Physical Training and Cancer-a Multicenter Clinical 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. 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

Interventions

BEHAVIORAL

high intensity exercise

high intensity exercise 80-90%

BEHAVIORAL

low/medium intensity exercise

low/medium intensity exercise 40-50%

BEHAVIORAL

Behavioral medicine strategies

Motivational and self-regulatory behavioral medicine support strategies

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Swedish Cancer Society

  collaborator OTHER

• Nordic Cancer Union

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Lund University

  collaborator OTHER

• University of Agder

  collaborator OTHER

• Copenhagen University Hospital, Denmark

  collaborator OTHER

• Norwegian School of Sport Sciences

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• University of Amsterdam

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Karin Nordin, Professor · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2024-12-31

Completion

2025-12-31