|Title||Can the prophylactic use of a combination of pentoxifylline and vitamin E reduce the incidence and severity of radiotherapy induced complications in head and neck cancer patients – a feasibility study|
|Study Type||Prospective Randomised Controlled Trial|
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Lay summary 300 words
Radiotherapy (RT) often causes unwanted side effects because normal cells are damaged by radiation. Tissue changes include scarring and radiation fibrosis, which causes muscle stiffening, immobility and pain. Head and neck cancer patients often experience swallowing problems while restricted mouth opening leads to inadequate diet, impaired speech, and poor oral hygiene.
Osteoradionecrosis (ORN) is a rare complication of RT causing areas of jawbone to become exposed and die. Advanced ORN causes jaw fractures so patients are unable to talk or eat and quickly become malnourished. ORN is difficult to treat. Surgery, if required, is long and complex and recovery may be incomplete. To date, the only semi-effective preventative measure is to have teeth, which are often healthy, extracted before RT.
A combination of pentoxifylline and vitamin E (PVe) can help to heal ORN. We therefore think that giving patients PVe after they finish their RT could reduce the incidence and severity of ORN. The RT-related changes that make the jaws vulnerable to ORN also damage facial, throat and neck muscles so PVe could also reduce fibrosis and mouth opening and swallowing problems.
This study will examine the feasibility of comparing PVe to a placebo (dummy pill). Patients will be randomly allocated to treatment groups so neither patients nor clinicians know which group they are in. Patients will be in the trial for 12 months. During standard quarterly review clinics, doctors will check whether patients have ORN. They will also measure mouth opening and neck fibrosis. Patients will complete questionnaires about their quality-of-life and swallowing. Our findings will inform the design of a larger definitive PVe study. Patients have been involved in the study design and will continue to provide input.
We will present our results in journals and at conferences and to patient H & N cancer groups and charities.