Most head and neck cancer is treated with a combination of surgery, radiotherapy and chemotherapy. Fibrosis, the hardening of tissue, is a common irreversible side effect of radiotherapy. It is estimated that up to 60% of these individuals will experience persistent fibrosis as toxic effect of the radiotherapy including trismus (locked jaw) and dysphagia (difficulty swallowing). These side effects have a big impact on one’s quality of life, due to impaired talking, eating, chewing and swallowing
PIT-STOP is a feasibility 36-month randomised trial of treatment with pentoxifylline and tocopherol in addition to best standard therapy (rehabilitation exercises) being compared to best standard therapy alone in 50 individuals with radiotherapy-induced fibrosis of the head and neck. It is a two-centre study with individual randomisation 1:1 into the two study arms. The aim outcome of this trial is to find out whether subjects will be willing to be randomised. Additional outcomes (secondary) will look at patient-centred measures, such as quality of life.
If this feasibility study is successful, the study team will explore a larger phase III study to determine if the medicines given in the feasibility trial are better or at least the same as standard of care, exercise regimens.