Identification of the mechanisms of 5-fluorouracil (5-FU)-induced Gastrointestinal (GI) toxicity in human colon - 5-FU-induced toxicity in GI system

niversiteit Maastricht0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年6月11日

试验速览

Trial ended prematurely

•- Metastatic breast cancer patients receiving capecitabine monotherapy as their
•regular first line treatment or second line treatment, which follows a first
•line treatment with taxanes and a recovery period of 3 weeks;
•- Triple-negative breast cancer patients, whose treatment consists of standard
•chemotherapy with taxanes, cyclophosphamide and anthracyclines, followed by
•surgery, and in case a complete remission is not observed, they receive
•neo-adjuvant monotherapy with capecitabine;
•- Advanced CRC cancer patients receiving capecitabine monotherapy as first or
•second line treatment, which follows a first line treatment with oxiplatin and
•a recovery period of at least 3 weeks;
•- Age above 18 years old;
•- Present with healthy colon tissue in the case of breast cancer patients.

•- 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;
•- Patients who were under chemotherapy with capecitabine/5-FU or took any
•chemotherapeutical similar to capecitabine/5-FU in a period less than 6 months;
•- - Current presence of any diseases related to the gastrointestinal tract,
•except advanced CRC cancer;;
•- 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.

发起方