Impact of the prophylactic gastrostomy for unresectable squamous cell head and neck carcinomas treated with radio-chemotherapy on quality of life: Prospective randomized trial.
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.
Salas
Sébastien
S
Service d'Oncologie Médicale Adulte, CHU Timone, APHM, Marseille, France.
Baumstarck-Barrau
Karine
K
Alfonsi
Marc
M
Digue
Laurence
L
Bagarry
Danielle
D
Feham
Nasreddine
N
Bensadoun
René Jean
RJ
Pignon
Thierry
T
Loundon
Anderson
A
Deville
Jean-Laurent
JL
Zanaret
Michel
M
Favre
Roger
R
Duffaud
Florence
F
Auquier
Pascal
P
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