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.
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.


CONCLUSIONS
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.


BACKGROUND
This study is registered at the Netherlands Trial Register (NTR 2159).
The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, The Netherlands.
Hanna
H
van Waart
Martijn M
MM
Stuiver
Wim H
WH
van Harten
Gabe S
GS
Sonke
Neil K
NK
Aaronson
D000553:Ambulatory Care / Q000191:economics*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D003110:Colonic Neoplasms / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D005080:Exercise Test; D005081:Exercise Therapy / Q000191:economics*; D005221:Fatigue / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D005260:Female; D017048:Health Care Costs; D006339:Heart Rate; D006699:Home Care Services / Q000191:economics*; D006801:Humans; D008297:Male; D053580:Muscle Strength; D009426:Netherlands; D010101:Oxygen Consumption; D010809:Physical Fitness; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome