Early preventive exercises versus usual care does not seem to reduce trismus in patients treated with radiotherapy for cancer in the oral cavity or oropharynx: A randomised clinical trial

Purpose. In head and neck cancer patients undergoing curative radiotherapy, we investigated the benefits and harms of an early exercise regime on trismus. Material and methods. Patients with head and neck cancer undergoing radiotherapy were centrally randomised to exercises 5-6 times for 45 minutes during and after radiotherapy supervised by a physiotherapist in addition to usual care versus usual care alone. The primary outcome was change in maximal interincisor distance (MID) measured at 5 and 12 months. Secondary outcomes were change in cervical ranges of motion, tissue tightness, and health-related quality of life. Mixed model analysis of repeated measures adjusted for tumour size and operation was conducted to assess the effect of early preventive exercises across time periods. Results. Of the 100 patients included, two patients withdrew and one died before the onset of radiotherapy. The unadjusted mean difference in MID at 12 months after having completed radiotherapy was 0.83 mm (95% confidence interval (CI) -3.64-5.29, p = 0.71) in the exercise intervention group compared with the control group. When adjusted for operation and tumour size, the effect of the exercise intervention on mean MID from baseline to 12-month follow-up was 5.92 mm (95% CI -0.48-12.33, p = 0.07). Of the secondary outcomes, cervical rotation showed a statistically significant deterioration in the exercise group compared with the control group (p = 0.01). No significant effects were observed on the other secondary outcomes. Conclusions. In patients with cancer in the oral cavity or oropharynx, early supervised exercises combined with self-care treatment focusing on mobility exercises to reduce trismus do not seem to provide additional beneficial effects compared with usual care during curative radiotherapy.