Feasibility and Adherence to Home-Based Intensive Treatment Programs for Chronic Radiation-Associated Dysphagia in Head and Neck Cancer Survivors-The HIT-CRAD Trial.

Abstract

The HIT-CRAD trial (ISRCTN57028065) is the first to combine home-based non-invasive brain stimulation with high-volume strength and skill training over 8 weeks in patients with chronic radiation-associated dysphagia (CRAD) following primary (chemo)radiotherapy for head and neck cancer. Fifty-four patients were randomized into three groups. Group 1 performed 8 weeks of strength training. Groups 2 and 3 combined 4 weeks of strength training with 4 weeks of skill training. Group 3 received high-definition transcranial direct current stimulation (HD-tDCS) during training. Group 2 received sham HD-tDCS. Overall adherence and exercise adherence remained above 75% across all groups. Home-based HD-tDCS proved safe and feasible, with mild to moderate side effects (tingling, itching, or burning). Median exercise performance levels for strength training exercises ranged from 94% to 100%. This study confirms the feasibility of high-volume strength and skill training with HD-tDCS in patients with C-RAD. Proactive adherence-supporting factors facilitate high adherence in this population. Both real and sham HD-tDCS proved safe, feasible, and well tolerated. International Standard Randomized Controlled Trials Number (ISRCTN) registry ID ISRCTN57028065.