title: Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial.
abstract: OBJECTIVE
  We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy, versus usual care, on one-year mortality.
  
  
  METHODS
  We conducted a multicentre, open-label interventional, stratified (centre), parallel randomised controlled trial, with a 1∶1 ratio, with two-year follow-up. Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition (MNA, Mini Nutritional Assessment 17-23.5). Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d, by face-to-face discussion targeting the main nutritional symptoms, compared to usual care. Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months. The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality, toxicities and chemotherapy outcomes.
  
  
  RESULTS
  Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed: mean (standard deviation) age of 78.0 y (4·9), 51.2% male, mean MNA 20.2 (2.1). Distribution of cancer types was similar in the two groups; the most frequent were colon (22.4%), lymphoma (14.9%), lung (10.4%), and pancreas (17.0%). Both groups increased their dietary intake, but to a larger extent with intervention (p<0.01). At the second visit, the energy target was achieved in 57 (40.4%) patients and the protein target in 66 (46.8%) with the intervention compared respectively to 13 (13.5%) and 20 (20.8%) in the controls. Death occurred during the first year in 143 patients (42.56%), without difference according to the intervention (p = 0.79). No difference in nutritional status changes was found. Response to chemotherapy was also similar between the groups.
  
  
  CONCLUSIONS
  Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes. Cancer cachexia antianabolism may explain this lack of effect.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00459589.
authors.affiliation: CHU Bordeaux, Clinical Gerontology, Bordeaux, France; CNRS, RMSB, UMR 5536, Bordeaux, France; Université Bordeaux, RMSB, UMR 5536, Bordeaux, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bourdel-Marchasson
authors.affiliation: CHU Bordeaux, Clinical Gerontology, Bordeaux, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Blanc-Bisson
authors.affiliation: CHU Bordeaux, Unité d'épidémiologie clinique, Bordeaux, France; INSERM, CIC-EC7, Bordeaux, France.
authors.forename: Adélaïde
authors.initials: A
authors.lastname: Doussau
authors.affiliation: CHU Bordeaux, Unité d'épidémiologie clinique, Bordeaux, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Germain
authors.affiliation: CHU Bordeaux, Hépatologie, gastroentérologie and oncologie digestive, Bordeaux, France; Université Bordeaux, Bordeaux, France.
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Blanc
authors.affiliation: Centre Hospitalier Layné-Mont de Marsan, Service Oncologie, Mont de Marsan, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Dauba
authors.affiliation: Centre Hospitalier Layné-Mont de Marsan, Service Oncologie, Mont de Marsan, France.
authors.forename: Cyril
authors.initials: C
authors.lastname: Lahmar
authors.affiliation: CHU Bordeaux, Service Hépato-gastro et oncologie digestive, Bordeaux, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Terrebonne
authors.affiliation: Polyclinique Bordeaux Nord, Service hépato gastroentérologie, Bordeaux, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Lecaille
authors.affiliation: Centre Hospitalier de Libourne, Libourne, France.
authors.forename: Joël
authors.initials: J
authors.lastname: Ceccaldi
authors.affiliation: Clinique Francheville, Périgueux, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Cany
authors.affiliation: CHU Limoges, Unité de recherche clinique en oncologie médicale, Limoges, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Lavau-Denes
authors.affiliation: Institut Bergonié, Departement d'oncologie médicale, Bordeaux, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Houede
authors.affiliation: Institut Bergonié, Departement d'oncologie médicale, Bordeaux, France.
authors.forename: François
authors.initials: F
authors.lastname: Chomy
authors.affiliation: CHU Bordeaux, Clinical Gerontology, Bordeaux, France.
authors.forename: Jessica
authors.initials: J
authors.lastname: Durrieu
authors.affiliation: Institut Bergonié, Departement d'oncologie médicale, Bordeaux, France; Université Bordeaux, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Soubeyran
authors.affiliation: Universités Montpellier 1 et 3, Laboratoire Epsylon EA 4556, Montpellier, France; CLCC du Val d'Aurelle, Unité de Nutrition clinique et de gastroentérologie, Montpellier, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Senesse
authors.affiliation: CHU Bordeaux, Unité d'épidémiologie clinique, Bordeaux, France; INSERM, CIC-EC7, Bordeaux, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Chene
authors.affiliation: Institut Bergonié, Departement d'oncologie médicale, Bordeaux, France.
authors.forename: Mariane
authors.initials: M
authors.lastname: Fonck
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002100:Cachexia; D003376:Counseling; D004032:Diet; D002149:Energy Intake; D005260:Female; D006801:Humans; D008297:Male; D044342:Malnutrition / Q000401:mortality*; D009369:Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D009752:Nutritional Status; D015431:Weight Loss
chemical_list: D000970:Antineoplastic Agents