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Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. ntravier@iconcologia.net. Unit of Nutrition and Cancer, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, 08907, Spain. ntravier@iconcologia.net. Department of Clinical Sciences, University of Barcelona, Barcelona, 08907, Spain. ntravier@iconcologia.net. Comprehensive Cancer Organisation (IKNL), PO Box 19079, 3501 DB, Utrecht, The Netherlands. m.velthuis@iknl.nl. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. cnsteinsbisschop@gmail.com. Department of Rehabilitation, Nursing Sciences and Sport, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. b.j.w.vandenbuijs@umcutrecht.nl. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. e.monninkhof@umcutrecht.nl. Department of Rehabilitation, Nursing Sciences and Sport, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. f.j.g.backx@umcutrecht.nl. Medical Oncology, St. Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands. m.los@antoniusziekenhuis.nl. Internal Medicine - Medical Oncology, Obis Medisch Centrum, Dr vander Hoffplein 1, 6166 BG, Sittard-Geleen, The Netherlands. f.erdkamp@orbisconcern.nl. Department of Internal Medicine, Medical Center, Maatweg 3, 3818 TZ, Amersfoort, The Netherlands. h.bloemendal@meandermc.nl. Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. c.c.rodenhuis@umcutrecht.nl. Department of Surgery, Ziekenhuis Rivierenland, President Kennedylaan 1, 4002 WP, Tiel, The Netherlands. m.de.roos@zrt.nl. Department of internal medicine, Hofpoort Ziekenhuis, Polanerbaan 2, 3447 GN, Woerden, The Netherlands. mverhaar@zuwehofpoort.nl. Internal Medicine, Diakonessenhuis, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands. dtbokkelhuinink@diakhuis.nl. Cancer Center, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. e.vanderwall@umcutrecht.nl. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. p.h.m.peeters@umcutrecht.nl. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. a.m.may@umcutrecht.nl.

BMC medicine. 2015;:121
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Abstract

BACKGROUND Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. METHODS This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. RESULTS Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. CONCLUSIONS A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up. TRIAL REGISTRATION Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.

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MeSH terms : Exercise Therapy ; Fatigue