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An observational study to assess the ability of the thymine loading test to prospectively categorise patients with gastrointestinal or breast cancer who cannot tolerate fluoropyrimidine treatment.

An observational study to assess the ability of the thymine loading test to prospectively categorise patients with gastrointestinal or breast cancer who cannot tolerate fluoropyrimidine treatment.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001109392
Acronym
THYmine 2
Enrollment
166
Registered
2017-07-28
Start date
2017-11-23
Completion date
2022-01-19
Last updated
2022-06-06

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 primary aim of this study is to determine whether the ratio of thymine to dihydrothymine (THY/DHT) measured in a urine sample after a thymine test dose (250 mg, taken orally) can discriminate between patients who tolerate 5-FU treatment and those who experience severe 5-FU related toxicity.

Interventions

This study is an observational study. Thymine test results will not affect any treatment decisions. At a scheduled assessment clinic visit, >24 hours prior to the commencement of treatment with 5-FU/capecitabine containing schedules: A baseline blood sample will be obtained (one 10 ml sample) as well as a baseline spot urine sample. A cheek (buccal) cell sample will also be obtained. This will involve using a cytobrush to take a brushing of the inside of the cheek (like using a toothbrush on t

This study is an observational study. Thymine test results will not affect any treatment decisions. At a scheduled assessment clinic visit, >24 hours prior to the commencement of treatment with 5-FU/capecitabine containing schedules: A baseline blood sample will be obtained (one 10 ml sample) as well as a baseline spot urine sample. A cheek (buccal) cell sample will also be obtained. This will involve using a cytobrush to take a brushing of the inside of the cheek (like using a toothbrush on the inside of the mouth). This will be done twice (one on each side of the mouth) and will require a mouth wash with water prior to the first brushing. The participants will then be administered thymine (250 mg, oral gelatine capsule) with a drink of water. A cumulative (total) urine sample will be collected for the next 4 hours. All patients who have been given the thymine test will then continue on their planned chemotherapy treatment. All patients will be assessed for adverse events related to 5-FU/capecitabine treatment. Information will be collected at each scheduled clinic visit for 8 – 9 weeks while on normal chemotherapy treatment. Analysis will involve urine sample for thymine and its metabolite (dihydrothymine or DHT). Cheek cells will be used to assess 5-FU uptake in vitro and genomic DNA (from blood) will be used to analysing variation in the DPYD gene and further analysis of genes associated with 5-FU side effects.

Sponsors

University of Auckland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Age >18 years. - To receive 5-FU or capecitabine (GI) or capecitabine (mBC) as part of standard care for histologically or cytologically confirmed gastrointestinal (GI) cancer or metastatic breast cancer (mBC); OR - To receive capecitabine as part of standard care for residual disease present at surgery following neoadjuvant chemotherapy for breast cancer - Able to provide written informed consent

Exclusion criteria

- Pregnant or breast feeding - Concurrent abdomino-pelvic radiation therapy - Irinotecan containing schedules - Prior history of infusional 5-FU or capecitabine

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026