A van der Werf1, J A E Langius2, A Beeker3, A J Ten Tije4, A J Vulink5, A Haringhuizen6, J Berkhof7, H J van der Vliet8, H M W Verheul8, M A E de van der Schueren9. 1. Department of Medical Oncology, Amsterdam UMC, Vrije Universiteit, Cancer Center Amsterdam, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands; Department of Nutrition and Dietetics, Internal Medicine, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands. Electronic address: an.vanderwerf@vumc.nl. 2. Department of Nutrition and Dietetics, Internal Medicine, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands; Department of Nutrition and Dietetics, Faculty of Health, Nutrition and Sport, The Hague University of Applied Sciences, P.O. Box 13336, 2501 EH, The Hague, the Netherlands. 3. Department of Medical Oncology, Spaarne Gasthuis, P.O. Box 417, 2000 AK, Haarlem, the Netherlands. 4. Department of Medical Oncology, Amphia Ziekenhuis, P.O. Box 90157, 4800 RL, Breda, the Netherlands. 5. Department of Medical Oncology, Reinier de Graaf Gasthuis, P.O. Box 5011, 2600 GA, Delft, the Netherlands. 6. Department of Medical Oncology, Ziekenhuis Gelderse Vallei, P.O. Box 9025, 6710 HN, Ede, the Netherlands. 7. Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands. 8. Department of Medical Oncology, Amsterdam UMC, Vrije Universiteit, Cancer Center Amsterdam, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands. 9. Department of Nutrition and Dietetics, Internal Medicine, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands; Department of Nutrition and Health, Faculty of Health and Social Studies, HAN University of Applied Sciences, P.O. Box 6960, 6503 GL, Nijmegen, the Netherlands.
Abstract
BACKGROUND & AIMS: A low muscle mass before start of treatment and loss of muscle mass during chemotherapy is related to adverse outcomes in patients with cancer. In this randomized controlled trial, the effect of nutritional counseling on change in muscle mass and treatment outcome in patients with metastatic colorectal cancer during first-line chemotherapy was studied. METHODS: Patients scheduled for first-line chemotherapy (n = 107) were randomly assigned to individualized nutritional counseling by a dietitian (NC) or usual care (UC). NC was aimed at sufficient protein- and energy intake, supported by oral supplements or enteral feeding if indicated. Furthermore, physical activity was encouraged. Outcomes were assessed at baseline (T0) and the time of the first (T1) and second (T2) regular follow-up computed tomography scans. The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2, measured by computed tomography, was the primary outcome. Secondary outcomes included body weight, quality of life, treatment toxicity and progression free and overall survival. RESULTS: A total of 107 patients were enrolled (mean age, 65 years (SD, 11 years), 63% male). Mean change in skeletal muscle area from T0 till T1 was -2.5 (SD, 9.5) cm2, with no difference between NC versus UC (p = 0.891). The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2 did not differ (NC 30% versus UC 31%, p = 0.467). NC compared with UC had a significant positive effect on body weight (B coefficient 1.7, p = 0.045), progression free survival (p = 0.039) and overall survival (p = 0.046). CONCLUSIONS: NC of patients undergoing chemotherapy for metastatic colorectal cancer had no effect on muscle mass. However, we found that NC may increase body weight and improve progression free survival and overall survival compared to UC in this group of patients. These findings need further evaluation in future clinical trials. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov NCT01998152; Netherlands Trial Register NTR4223.
RCT Entities:
BACKGROUND & AIMS: A low muscle mass before start of treatment and loss of muscle mass during chemotherapy is related to adverse outcomes in patients with cancer. In this randomized controlled trial, the effect of nutritional counseling on change in muscle mass and treatment outcome in patients with metastatic colorectal cancer during first-line chemotherapy was studied. METHODS:Patients scheduled for first-line chemotherapy (n = 107) were randomly assigned to individualized nutritional counseling by a dietitian (NC) or usual care (UC). NC was aimed at sufficient protein- and energy intake, supported by oral supplements or enteral feeding if indicated. Furthermore, physical activity was encouraged. Outcomes were assessed at baseline (T0) and the time of the first (T1) and second (T2) regular follow-up computed tomography scans. The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2, measured by computed tomography, was the primary outcome. Secondary outcomes included body weight, quality of life, treatment toxicity and progression free and overall survival. RESULTS: A total of 107 patients were enrolled (mean age, 65 years (SD, 11 years), 63% male). Mean change in skeletal muscle area from T0 till T1 was -2.5 (SD, 9.5) cm2, with no difference between NC versus UC (p = 0.891). The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2 did not differ (NC 30% versus UC 31%, p = 0.467). NC compared with UC had a significant positive effect on body weight (B coefficient 1.7, p = 0.045), progression free survival (p = 0.039) and overall survival (p = 0.046). CONCLUSIONS: NC of patients undergoing chemotherapy for metastatic colorectal cancer had no effect on muscle mass. However, we found that NC may increase body weight and improve progression free survival and overall survival compared to UC in this group of patients. These findings need further evaluation in future clinical trials. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov NCT01998152; Netherlands Trial Register NTR4223.
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