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UCL Division of Surgery and Interventional Science

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PITSTOP Trial Information

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.