Long-term Adverse Effects of Radiotherapy for Pelvic Cancer Clinical Trial
Official title:
Randomised Double-blind Placebo Controlled Phase II Trial of Tocovid SupraBio in Combination With Pentoxifylline (PTX) in Patients Suffering Long-term Adverse Effects of Radiotherapy for Pelvic Cancer
Side effects are common after treatment with radiotherapy for tumours in the pelvis and can
affect the way the bowel and urinary system work as well as causing sexual difficulties, skin
damage and bone problems. Problems in the bowel, bladder, sexual organs and skin mostly
result from thickening of the tissues in response to radiotherapy, a process called
"fibrosis". Fibrosis often worsens over time.
There has been progress in treating bowel symptoms which usually are the worst problem after
radiotherapy. However, even after receiving the best possible treatments, while many patients
are better, they are often not cured of all their difficult problems.
For some years, it has been hypothesised that if fibrosis could be treated then symptoms
would improve. Recent research in laboratory animals has suggested that an effective
treatment for radiation-induced fibrosis is combination therapy with a drug called
Pentoxifylline together with a nutritional supplement containing gamma-tocotrienol (Tocovid
SupraBio), a substance derived from palm oil. Both of these agents are simple to take and
side effects are rare.
This study will recruit volunteers who continue to have difficult side effects after previous
radiotherapy to the pelvis despite receiving the best treatments available from a unique
clinic at The Royal Marsden which has pioneered treatment for bowel problems after
radiotherapy. Two out of every three volunteers who take part, will be randomly assigned to
treatment with Pentoxifylline and Tocovid SupraBio, while one out of three will receive dummy
pills. Neither the patients nor the staff assessing them will know which treatment they have
been given. Volunteers take the active treatments or dummy tablets for a year and will be
assessed regularly while on treatment and for a year afterwards. This study will show whether
active treatment is more effective than dummy pills in improving the symptoms caused by
radiation-induced fibrosis.
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