Efficacy of exercise therapy during radiotherapy to prevent reduction in mouth opening in patients with head and neck cancer: A randomized controlled trial.

OBJECTIVE: The aim of this study was to compare the efficacy of 2 protocols of exercise therapy to avoid reduction in mouth opening (MO) in patients undergoing radiotherapy for head and neck cancer. STUDY DESIGN: This was a randomized, controlled, double-blind, 3-arm, parallel-group, prevention clinical trial. Ninety patients were randomized into 3 groups to perform exercises during radiotherapy treatment: intervention group 1 (G1); intervention group 2 (G2); and control group (CG). Maximum MO was measured before (T0), immediately after (T1), and at 12 months (T2) after completion of radiotherapy treatment. Generalized estimating equations model complemented by the least significant difference test was applied to group comparisons. RESULTS: There was no significant difference in MO measure between the groups at the 3 assessment time points (P = .264). The difference in MO measure from baseline to 12 months after having completed radiotherapy was -1 mm in CG (95% confidence interval [CI] -4.0 to 2.0); 1.3 mm in G1 (95% CI -1.7 to 4.3); and 0.5 mm in G2 (95% CI -3.4 to 4.4). CONCLUSIONS: It was not possible to conclude that the exercise protocols performed in this study are more effective than the usual guidance to prevent reduction in MO in patients undergoing radiotherapy for head and neck cancer.