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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000268347

Acronym

DPD study

Enrollment

Registered

2008-05-28

Start date

2009-04-22

Completion date

2009-11-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Trial completed with 6 subjects recruited. The breath test was not useful in predicting %FU toxicity. The Thymine test was useful in identifying soem patients with 5FU toxicity.

Interventions

uracil breath test (once off test), thymine assay of saliva, blood and urine, genetic analysis of blood. The testing will be completed over 2 days once informed consent is signed. These tests are not standard practice. The testing will be done on patient who exeprienced 5FU toxicity up to 1 year ago.

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

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.

Outcome results