The ability of a uracil breath test and a thymine loading test to correctly identify patients who have experienced severe 5-Fluorouracil (5FU) toxicity.

Not Applicable

Completed

• Conditions: 5-Fluorouracil toxicity; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12608000268347
• Lead Sponsor: Southern Health, Monash Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Have recieved a solely 5FU based chemotherapy treatment in the past with severe toxicity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events; grade 3-4 toxicity in 2 or more catagories with at least one hematological and one non-hematological toxicity.
No clinically significant hepatic or renal impairment.

Exclusion Criteria

Pregnancy or breast feeding.
Any known inherited disorder of metabolism.
Any severe respiratory disorder.
Any acute or chronic gastrointestinal disorder interfering with absorption.
Inability to give written informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified