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Prospective Study in Pelvic Radiotherapy Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220181
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose

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 don't experience bowel symptoms during their course of radiotherapy.


Condition
Gynaecological, Urological or Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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.

Further study details as provided by Royal Marsden NHS Foundation Trust:

Estimated Enrollment: 100
Study Start Date: April 2003
Estimated Study Completion Date: September 2005
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient with gynaecological, bladder or rectal malignancy about to embark ona 5-6 week course of radical radiotherapy to the pelvis who is able to give informed consent

Exclusion Criteria:

  • Patients unable or unwilling to give informed consent
  • Patients who have already started radiotherapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220181


Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Jervoise Andreyev Imperial College London
  More Information

ClinicalTrials.gov Identifier: NCT00220181     History of Changes
Other Study ID Numbers: CCR2240
First Submitted: September 21, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Royal Marsden NHS Foundation Trust:
Nutritional status
Bowel symptoms
Radical radiotherapy to pelvis
Gynaecological, urological or rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases