Prophylactic Versus Reactive (PvR) Feeding in Patients Undergoing (Chemo)radiation in Head and Neck Cancers: Results of a Phase III Randomized Controlled Trial.

Abstract

Optimal feeding strategy (Prophylactic vs. Reactive) during Radiation Therapy (RT) for Head and Neck Cancers (HNC) remains to be established. This phase III trial randomized (1:1) patients of HNC to prophylactic [nasogastric tube (NGT) placed at least 1 day before RT starting] versus reactive arm (NGT when required). The primary endpoint was the incidence of significant weight loss at 6 months. Secondary endpoints were weight changes, tube duration, dependence, and compliance. Due to high denial rates, the trial was prematurely closed. Eighty-four patients (40-prophylactic, 44-reactive) were analyzed intention-to-treat. Seventeen patients (39%) required a reactive tube insertion. The proportion of patients with significant weight loss at 6 months in the prophylactic versus reactive arms was 13 (32.5%) versus 10 (15.9%), p = 0.44. The median tube duration was 56 days (IQR: 16.5-91) versus 47 days (IQR: 24-59), p = 0.255. Our limited analysis found that a reactive NGT should be considered for most HNC patients undergoing RT. Clinical trials registry of India: CTRI/2020/01/023049.