The ‘PIT-STOP’ trial will specifically look at the effect of combining two medications, Pentoxifylline and Vitamin E, in order to reduce soft tissue fibrosis of the mouth and throat in head and neck cancer (HNC) survivors.
Lead researcher, Professor Stefano Fedele, said: “Fibrosis in these individuals is characterised by a hardening of mouth muscles, including those of the back of the mouth and throat.”
“It restricts mouth opening and reduces the ability to talk, chew and swallow, which can severely impact quality of life.
“It can also cause malnutrition and pneumonia due to the entry of food and liquids in the respiratory tract, which can increase mortality.
"HNC survivors who have defeated their cancers are often left with this chronic condition caused by their life-saving, anti-cancer therapy and there is no realistic therapeutic option, no intervention that has proven to be effective in the long-term."
In UK there are around 10,000 new HNC cases each year – leading to approximately 4,200 individuals experiencing post-radiotherapy fibrosis.
Co-administration of Pentoxifylline and Vitamin E has had promising results in individuals irradiated to the breast, pelvis, lung, and prostate.
The team hope that it could also reverse or reduce fibrosis in HNC survivors.
The new preliminary study will recruit 40 participants in London and Liverpool, and run over 3 years.
This independent research is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1215-20002). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
