title: Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Malnutrition is a common complication in patients at the palliative stage of cancer. During the curative phase of cancer, optimal enteral or parenteral nutrition intake can reduce morbidity and mortality, and improve quality of life. When the main goal of treatment becomes palliative, introduction of artificial nutrition is controversial. Although scientific societies do not recommend the introduction of artificial nutrition in all cases of malnutrition, especially in hypophagic patients if their life expectancy is shorter than 2 months, considerable differences in the use of parenteral nutrition in nonsurgical oncology practice are noted around the world. One explanation is a paucity of well-conducted randomized controlled trials in these situations, and consequently, the risk/benefit ratio of parenteral nutrition and its impact on quality of life in palliative care remains uncertain.
  
  
  METHODS
  The ALIM-K study is a French national multicenter randomized controlled trial designed to evaluate the effectiveness of parenteral nutrition, versus an exclusive oral-feeding supply, on the quality of life of malnourished patients who have a functional digestive tube and who are at the palliative phase of advanced cancer with a life expectancy of more than 2 months.
  
  
  CONCLUSIONS
  This article presents the methodologic options chosen for our study, and in particular, the choice of the Zelen method of randomization, the definition of the main end point (quality of life), the choice of comparator (oral feeding), and the inclusion criteria (life expectancy of more than 2 months), which are all critical points in building a randomized controlled trial in the setting of palliative care.
  
  
  BACKGROUND
  This study was registered with the clinical trials database ClinicalTrials.gov on May 27, 2014, under the number NCT02151214.
authors.affiliation: Inserm CIC 1431, CHRU de Besançon, Besançon, France. lionel.pazart@gmail.com.
authors.forename: Lionel
authors.initials: L
authors.lastname: Pazart
authors.forename: Elodie
authors.initials: E
authors.lastname: Cretin
authors.forename: Ghislain
authors.initials: G
authors.lastname: Grodard
authors.forename: Cecile
authors.initials: C
authors.lastname: Cornet
authors.forename: Florence
authors.initials: F
authors.lastname: Mathieu-Nicot
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Mariette
authors.initials: M
authors.lastname: Mercier
authors.forename: Patrice
authors.initials: P
authors.lastname: Cuynet
authors.forename: Carole
authors.initials: C
authors.lastname: Bouleuc
authors.forename: Regis
authors.initials: R
authors.lastname: Aubry
mesh_terms: D002985:Clinical Protocols; D005602:France; D006801:Humans; D008017:Life Expectancy; D044342:Malnutrition / Q000175:diagnosis / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D009367:Neoplasm Staging; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D010166:Palliative Care / Q000379:methods*; D010288:Parenteral Nutrition; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome