Thymine test for 5-fluorouracil side effects

An observational case-control study to detect predisposition to 5-fluorouracil/capecitabine-related toxicity using a thymine test in gastrointestinal cancer patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000586516

Enrollment

Registered

2015-06-04

Start date

2015-04-21

Completion date

2017-07-26

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

The aim of this study is to determine whether the thymine test can appropriately characterise a patients ability to tolerate 5FU treatment.

Interventions

Participants are administered a single dose of thymine (250 mg, orally) at any time prior to, or after completion of, a cycle of 5-fluorouracil/capecitabine treatment course. A cumulative 4 h urine sample is collected for detemination of the amount of thymine and metabolites excreted

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients diagnosed with histologically confirmed gastrointestinal cancers or metastatic breast cancer; about to start or have commenced therapy with single agent 5FU or capecitabine

Exclusion criteria

Pregnant or breast feeding; concurrent adbominopelvic radiation therapy

Outcome results