A Prospective Study to Identify Changes in Nutritional Status and Bowel Symptoms in Patients Receiving a Course of Radical Radiotherapy to the Pelvis for Treatment of Gynaecological, Urological or Rectal Cancer.
Patients with pelvic cancers may be treated with radical radiotherapy as part of their
disease management. Acute intestinal changes such as diarrhoea, abdominal pain and nausea
ocur in about 75% of patients. Severe acute changes predispose to chronic, intractable
intestinal changes. Nutritional intervention during radiotherapy may protect the bowel from
toxicity.
A number of nutritionally related changes in bowel function may cause acute intestinal
problems during radiotherapy. These include: Bile-acid & pancreatic enzyme potentiated
damage to mucosa causing loss of epithelial integrity and in turn increased permeability to
antigens and luminal bacteria; Bile-acid malabsorption, decreasing the gut's ability to
digest fat; Reduced disaccharidase activity due to loss of the intestinal brush border,
causing malabsorption of sugars leading to osmotic diarrhoea; Statis/ dysmotility in the
small intestine prompting bacterial overgrowth.
There is little prospective data in patients undergoing radiotherapy to help to identify
which are important. To understand what changes are relevant during a 6-week course of
radiotherapy we plan this prospective observational study. Any changes identified in this
study could be ameliorated by specific nutritional intervention in future studies.
Observational
Observational Model: Case Control, Observational Model: Natural History, Time Perspective: Cross-Sectional, Time Perspective: Prospective
Jervoise Andreyev
Principal Investigator
Imperial College London
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CCR2240
NCT00220181
April 2003
September 2005
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