Impact of the prophylactic gastrostomy for unresectable squamous cell head and neck carcinomas treated with radio-chemotherapy on quality of life: Prospective randomized trial

摘要: Abstract Background and purpose Concomitant radio-chemotherapy is the gold standard treatment for unresectable head neck carcinomas. Placement of prophylactic gastrostomy has been proposed to provide adequate nutrition during therapeutic sequence. The objectives this study were assess impact on 6-month quality life, determine factors related life. Materials methods Design. randomized, controlled, open ("systematic percutaneous gastrostomy" versus "no systematic gastrostomy"). Patients. squamous cell carcinoma (stages III IV, UICC 1997). Setting. oncological departments French university teaching hospitals. Treatment. optimal concomitant radio-chemotherapy. Evaluations. T0 baseline evaluation, T1 treatment, T2 end T3 post-inclusion. Primary endpoint. life (Qol) assessed using SF36, EORTC QLQ-C30, QLQ H&N35 questionnaires. Results Qol changes from included a decline (T1 T2) followed by an improvement (T3). at 6 months was significantly higher in group receiving ( p =10 −3 ). Higher initial BMI lower Karnofsky index significant Qol. Conclusions results suggest that improves post-treatment cancer patients, after adjusting other potential predictive factors.