The long term follow-up of a prospective randomised controlled trial of nutritional therapy in head and neck cancer patients submitted to radiotherapy

Abstract

17000 Background: A randomized controled trial conducted in 75 head-neck cancer (HNC) patients, proved individualized nutritional counseling to be the most effective regimen in reducing RT toxicity, improving nutritional intake & status, & Quality of Life, persisting at 3 months after intervention. The present aim was to assess survival & late RT toxicity after a long term follow-up. Methods: Original study groups comprised: G1=25 received individualized nutritional counseling & education (regular foods), G2=25 ad lib+2 polymeric protein supplements & G3=25 ad lib intake. Some data was collected from patients’ records at follow-up appointments every 3–6 months; in addition, validated questionnaires to assess symptoms were used at programmed interviews after a median follow-up of 3.8 (range 2.0–6.3) yrs (PR). Analyses, per group & in-between group comparisons were adjusted for cancer stage, age, follow- up time, & survival. Results: Kaplan Meier method was used to calculate survival curves: in G1, 4 (16%) patients died, in G2 there were 8 (32%) deaths & 12 (48%) patients died in G3, p<0.05. Late RT toxicity (permanent xerostomia and/or taste alterations) was higher in G3 & G2 by comparison to G1, p<0.04; those symptoms were experienced and/or reported by 10 (80%) of G3 patients, by 12 (72%) of G2 patients and by 10 (52%) patients in G1: G3≈G2>G1, p=0.05. Conclusions: This study is the first to convey information on long term follow-up designed to assess the possible effectiveness of nutrition as adjuvant therapy throughout RT treatment in HNC patients; altogether early individualized nutritional counseling & education seems to improve well-being and possibly prognosis. No significant financial relationships to disclose.