Session Item

Prophylactic versus reactive enteral nutrition in HN radiotherapy patients is being evaluated as an ongoing RCT at our institute that has been challenged with subpar accrual rates (53% of screened patients accrued in first year that was only 40% of expected numbers). By analyzing our screen-log (eligible patients not enrolled in the study), we intend to understand the significance of trial question and continue the RCT with revisions if required.

Amongst 148 patients screened, 78 are accrued in the RCT and 70 are screen failures (Reasons being not willing for participation-62, accrual in studies that would confound results of our study-4, seemingly non-compliant-1, preferred treatment outside-1). Differences between those requiring and not requiring reactive tube insertion in terms of weight loss, overall treatment time (OTT), acute toxicities, compliance and tube dependence were studied.

A male predominance (81.4%), mean age of 52 years, oral cavity as commonest site (61.4%) and a majority of advanced disease was observed. Radiation was delivered as adjuvant therapy in 63% and definitive therapy in 37%. 68% and 32% were treated with conventional and conformal techniques respectively. 53% received concurrent chemotherapy, 3 weekly cisplatin being the commonest regimen. 22 patients (31%) required reactive tube insertion, however only 15 complied (21%). This was more in line with reactive insertions in our RCT cohort (34%).  Only 1 patient out of 7 who didn’t comply couldn’t complete planned treatment due to toxicities. Mean OTT was 41 days and 3 patients exceeded the expected OTT. Median tube duration (NGT in situ duration) was 73 days. 40, 80 and 67% patients developed ≥grade2 dermatitis, mucositis and dysphagia respectively. Higher incidence of dysphagia was noted in patients who did not undergo reactive tube placement, however this did not affect completion rates. Median follow-up was 8.5 months (range: 3 to 26 months). No statistical differences were observed in weight changes (including significant weight loss at 6 months – primary outcome of RCT) or OTT for patients requiring and not requiring a reactive tube insertion. Chi-square showed significant association between requirement of reactive tube with respect to site(p=0.002), subsite(p=0.034), chemotherapy drug(p=0.006). Significant weight loss was associated with treatment modality(p=0.01) and concurrent chemotherapy(p=0.02). Overall, 12 patients experienced significant weight loss of ≥10% at conclusion of which 66% had undergone reactive tube insertion.

Analysis of patients in the screen failed population did not reveal any statistically significant differences in outcomes between patients who had a reactive tube placement versus those who did not have a tube placement. Certain parameters like specific site, the use of concurrent chemotherapy help identify patients who may be at higher risk or need a reactive tube placement. This underlines the importance of continuing with the RCT.