title: Impact of the prophylactic gastrostomy for unresectable squamous cell head and neck carcinomas treated with radio-chemotherapy on quality of life: Prospective randomized trial.
abstract: OBJECTIVE
  Concomitant radio-chemotherapy is the gold standard treatment for unresectable head and neck carcinomas. Placement of prophylactic gastrostomy has been proposed to provide adequate nutrition during the therapeutic sequence. The objectives of this study were to assess the impact of prophylactic gastrostomy on the 6-month quality of life, and to determine the factors related to this quality of life.
  
  
  METHODS
  Design. randomized, controlled, open study ("systematic percutaneous gastrostomy" versus "no systematic gastrostomy"). Patients. squamous cell head and neck carcinoma (stages III and IV, UICC 1997). Setting. oncological departments of French university teaching hospitals. Treatment. optimal concomitant radio-chemotherapy. Evaluations. T0 baseline evaluation, T1 during the treatment, T2 end of the treatment, and T3 6-month post-inclusion. Primary endpoint. 6-month quality of life (Qol) assessed using SF36, EORTC QLQ-C30, EORTC QLQ H&N35 questionnaires.
  
  
  RESULTS
  The Qol changes from baseline included a decline (T1 and T2) followed by an improvement (T3). Qol at 6 months was significantly higher in the group receiving systematic prophylactic gastrostomy (p=10(-3)). Higher initial BMI and lower initial Karnofsky index were significant factors related to a higher 6-month Qol.
  
  
  CONCLUSIONS
  The study results suggest that prophylactic gastrostomy improves post-treatment quality of life for unresectable head and neck cancer patients, after adjusting for other potential predictive quality of life factors.
authors.affiliation: Service d'Oncologie Médicale Adulte, CHU Timone, APHM, Marseille, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Salas
authors.forename: Karine
authors.initials: K
authors.lastname: Baumstarck-Barrau
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.forename: Laurence
authors.initials: L
authors.lastname: Digue
authors.forename: Danielle
authors.initials: D
authors.lastname: Bagarry
authors.forename: Nasreddine
authors.initials: N
authors.lastname: Feham
authors.forename: René Jean
authors.initials: RJ
authors.lastname: Bensadoun
authors.forename: Thierry
authors.initials: T
authors.lastname: Pignon
authors.forename: Anderson
authors.initials: A
authors.lastname: Loundon
authors.forename: Jean-Laurent
authors.initials: JL
authors.lastname: Deville
authors.forename: Michel
authors.initials: M
authors.lastname: Zanaret
authors.forename: Roger
authors.initials: R
authors.lastname: Favre
authors.forename: Florence
authors.initials: F
authors.lastname: Duffaud
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004750:Enteral Nutrition; D005260:Female; D005774:Gastrostomy; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010039:Otorhinolaryngologic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D011788:Quality of Life