title: The effect of individualized nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: a randomized controlled trial protocol.
abstract: BACKGROUND
  A low muscle mass is prevalent in patients with metastatic colorectal cancer (mCRC) and has been associated with poor treatment outcome. Chemotherapeutic treatment has an additional unfavorable effect on muscle mass. Sufficient protein intake and physical activity are known to induce muscle protein anabolism in healthy individuals, however it is unclear whether optimal nutrition is effective to preserve muscle mass in patients with mCRC during first-line chemotherapy as well. We hypothesize that individual nutritional counseling by a trained dietitian during first-line chemotherapy is effective in preserving muscle mass and may improve clinical outcomes in patients with mCRC.
  
  
  METHODS
  In this multi-center single-blind randomized controlled trial, patients with mCRC scheduled for first-line combination chemotherapy consisting of oxaliplatin and fluoropyrimidine, with or without bevacizumab (n = 110), will be randomized to receive either individualized nutritional counseling by a trained dietitian to achieve a sufficient dietary intake and an adequate physical activity level, or usual care. Outcome measures will be assessed at baseline and after two and four months of treatment. The primary endpoint will be the change in skeletal muscle area (measured by CT-scan) at the first treatment evaluation. Secondary endpoints will be quality of life, physical functioning, treatment toxicity, treatment intensity and survival. Statistical analyses include one-sided t-tests for the primary endpoint and mixed models and the Kaplan-Meier method for secondary endpoints.
  
  
  CONCLUSIONS
  This randomized controlled trial will provide evidence whether individualized nutritional counseling during chemotherapy is effective in preventing loss of muscle mass in patients with mCRC.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01998152 ; Netherlands Trial Register NTR4223.
authors.affiliation: Department of Nutrition and Dietetics, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. an.vanderwerf@vumc.nl.|Department of Medical Oncology, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. an.vanderwerf@vumc.nl.
authors.forename: Anne
authors.initials: A
authors.lastname: van der Werf
authors.affiliation: Department of Nutrition and Dietetics, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. s.buskermolen@vumc.nl.|Department of Medical Oncology, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. s.buskermolen@vumc.nl.
authors.forename: Susanne
authors.initials: S
authors.lastname: Blauwhoff-Buskermolen
authors.affiliation: Department of Nutrition and Dietetics, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. j.langius@vumc.nl.|Faculty of Health, Nutrition and Sport, The Hague University of Applied Sciences, The Hague, The Netherlands. j.langius@vumc.nl.
authors.forename: Jacqueline A E
authors.initials: JA
authors.lastname: Langius
authors.affiliation: Department of Epidemiology en Biostatistics, VU University, Amsterdam, The Netherlands. h.berkhof@vumc.nl.
authors.forename: Johannes
authors.initials: J
authors.lastname: Berkhof
authors.affiliation: Department of Medical Oncology, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. h.verheul@vumc.nl.
authors.forename: Henk M W
authors.initials: HM
authors.lastname: Verheul
authors.affiliation: Department of Nutrition and Dietetics, Internal Medicine, VU University Medical Center, Amsterdam, The Netherlands. m.devanderschueren@vumc.nl.|Faculty of Health and Social Studies, Department of Nutrition, Sports and Health, HAN University of Applied Sciences, Nijmegen, The Netherlands. m.devanderschueren@vumc.nl.
authors.forename: Marian A E
authors.initials: MA
authors.lastname: de van der Schueren
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D037001:Directive Counseling; D006801:Humans; D018482:Muscle, Skeletal / Q000473:pathology*; D009362:Neoplasm Metastasis; D009752:Nutritional Status; D009929:Organ Size; D016896:Treatment Outcome