Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 Dec 7:10:673.
doi: 10.1186/1471-2407-10-673.

Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES): a randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

Hanna van Waart  1 , Martijn M Stuiver, Wim H van Harten, Gabe S Sonke, Neil K Aaronson
Affiliations
Randomized Controlled Trial

Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES): a randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue

Hanna van Waart et al. BMC Cancer. .

Abstract

Background: Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs.

Methods: This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up.

Discussion: This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy.

Trial registration: This study is registered at the Netherlands Trial Register (NTR 2159).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Overview of study procedures.
See this image and copyright information in PMC

References

    1. Courneya KS. Exercise in cancer survivors: an overview of research. Med Sci Sports Exerc. 2003;35:1846–1852. doi: 10.1249/01.MSS.0000093622.41587.B6. - DOI - PubMed
    1. Courneya KS, Friedenreich CM. Physical exercise and quality of life following cancer diagnosis: a literature review. Ann Behav Med. 1999;21:171–179. doi: 10.1007/BF02908298. - DOI - PubMed
    1. Hartvig P, Aulin J, Hugerth M, Wallenberg S, Wagenius G. Fatigue in cancer patients treated with cytotoxic drugs. J Oncol Pharm Pract. 2006;12:155–164. doi: 10.1177/1078155206070774. - DOI - PubMed
    1. Sitzia J, Dikken C. Survey of the incidence and severity of side effects reported by patients receiving six cycles of FEC chemotherapy. J Cancer Nurs. 1997;1:61–73. doi: 10.1016/S1364-9825(97)80184-8. - DOI
    1. Stone P, Richardson A, Ream E, Smith AG, Kerr DJ, Kearney N. Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum. Ann Oncol. 2000;11:971–975. doi: 10.1023/A:1008318932641. - DOI - PubMed

Publication types

MeSH terms