Effects of a short-term dietary restriction regimen in cancer patients receiving irinotecan. - Dietary restriction followed by irinotecan chemotherapy

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•*Metastatic colorectal cancer or other solid tumors
•*Eligible for treatment with irinotecan 600 mg 3-weekly
•*Age * 18 years
•*BMI 20-30kg/m2
•*WHO performance status 0-1
•*Written informed consent
•*Adequate renal function, i.e. serum creatinin < 2 x ULN and creatinin clearance > 45 mL/min
•*Patients with safely accessible liver metastases and healthy liver tissue
•*Adequate coagulation status (PT-INR <1.5, APTT<1.5xULN, on the day of biopsy in patients using coumarines: PT-INR<1.5, Hb>6mmol/L, trombocyten > 100x10 9)

•*Previous treatment with irinotecan within the last 6 months
•*Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required.
•*Serious illness or medical unstable condition prohibiting adequate treatment and follow-up.
•*History of bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
•*Patients using any anti-coagulant medication which cannot be safely stopped or counteracted at the time of biopsy
•*Unable or unwilling to stop the use of (over the counter) medication of (herbal) supplements which can interact with irinotecan (e.g. by induction or inhibition of CYP3A4 (see Appendix B))
•*Unable or unwilling to abstain from grapefruit or grapefruit juice during the study
•*Bilirubin > 1.5 x ULN, ASAT > 5x ULN, ALAT >5x ULN
•*Uncontrolled hypertension, despite medical treatment
•*Cows milk and/or soy allergy and/or lactose intolerance
•*Patients using insulin
•*Patients with hyperventilation
•*Patients unable of unwilling to fill in a food diary
•*Patients using oxygen and not able to stop for 30 minutes

发起方