EN: Gastrointestinal, 5-fluorouracil, Adverse effects, Toxicity NL: Gastrointestínaal, 5-fluorouracil, Schadelijke bijwerkingen, Toxiciteit
Conditions
Interventions
Colonic biopsy tissues will be collected before and after the treatment, after the first cycle of chemotherapy is completed. Blood and faecal samples will also be collected at that time points.
Sponsors
Maastricht University
Eligibility
Inclusion criteria
Inclusion criteria: - Metastatic breast cancer patients receiving capecitabine monotherapy as their regular treatment; - Age above 18 years old; - Present with healthy colon tissue
Exclusion criteria
Exclusion criteria: - Alcohol abuse up to 6 months before participation in this research, i.e. more than 4 drinks on any single day and more than 14 drinks per week for men and more than 3 drinks on any single day and more than 7 drinks per week for women - Current presence of any diseases related to the gastrointestinal tract - Current presence of symptoms related to diseases of the gastrointestinal tract, i.e. vomiting, diarrhoea or constipation, and altered stool, such as presence of blood - HIV infection or hepatitis - Use of antibiotics and other prescribed medication and painkillers over the last 3 months (exception: paracetamol and contraceptive) and during the chemotherapy. - Current smokers - Pregnant women - Participants of other clinical or dietary intervention studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the whole genome transcriptomic response after exposure to 5-FU in colon epithelium. | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular markers associated to 5-FU induced toxicity in the colon such as citrulline and calprotectin. | — |
Contacts
Public ContactDaniela Ferreira Garcia Rodrigues
Outcome results
None listed