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Clinical Trials/NL-OMON43513
NL-OMON43513
Completed
Not Applicable

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 sites18 target enrollmentTBD
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ConditionsCancer10027656

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
18
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\*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\)

Exclusion Criteria

  • •\*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

Outcomes

Primary Outcomes

Not specified

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