Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220181
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-21
Brief Title:
Prospective Study in Pelvic Radiotherapy Patients
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Symptoms such as diarrhoea and abdominal discomfort are common side effects of radiotherapy for tumours in the pelvis and usually occur within 2 weeks of starting treatment Once the course of radiotherapy has been completed these symptoms usually subside but in some patients they may continue and sometimes cause significant problems
It is not clear what processes are occurring to trigger such symptoms There are a number of possibilities and we would like to investigate these further If we can identify specific reasons for symptoms being worse in one patient compared to another then we can try to either prevent or treat these The aim of this study is to look for differences in the way that the bowel adapts to radiotherapy in patients who do and those who dont experience bowel symptoms during their course of radiotherapy
It is not clear what processes are occurring to trigger such symptoms There are a number of possibilities and we would like to investigate these further If we can identify specific reasons for symptoms being worse in one patient compared to another then we can try to either prevent or treat these The aim of this study is to look for differences in the way that the bowel adapts to radiotherapy in patients who do and those who dont experience bowel symptoms during their course of radiotherapy
Detailed Description:
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 guts 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
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 guts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None