None listed
Conditions
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 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
Eligibility
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