Head and Neck cancer
Conditions
Interventions
None.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Histological or cytological confirmed diagnosis of any form of irresectable Head and Neck cancer, which is not currently being treated with cisplatin; •Treatment with high doses of cisplatin (3-weekly 100 mg/m2), with radiotherapy. No other systemic anti-cancer treatment is allowed. • Age =/>18 years; • WHO performance =/ 1.5 x 109/L, platelets > 100 x 1012/L) •Adequate renal and hepatic functions (serum creatinin
Exclusion criteria
Exclusion criteria: •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 requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent; •Current use of cisplatin therapy; •Patients with Chronic Kidney Disease; •Major surgery within 4 weeks before start of the protocol (to be evaluated by an MD); •(Chronic) use of CYP3A and/or ABCB1/ABCG2 inhibiting and inducing medication, dietary supplements, or other inhibiting compounds (see Appendix D); •Unwillingness to change medication, or no adequate alternatives available, when drugs are taken that are known to interact with CYP3A and/or ABCB1 and/or ABCG2; •Use of cimetidine 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective •To investigate the ability of cimetidine to prevent cisplatin-induced nephrotoxicity, while not impairing the efficacy of cisplatin in Head and Neck cancer patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3.2 Secundary objective •To relate single-nucleotide polymorphisms in the drug transporting proteins to the pharmacokinetics and -dynamics of cisplatin treatment. Amendement: Nephrotoxicity is a well-known adverse effect of cisplatin treatment. In this clinical study we investigate the effects of cimetidine on cisplatin induced nephrotoxicity. Nephrotoxicity is quantitfied by classic clinical markers (like serum creatinine) as well as a commercially available N-acetyl-β- D-glucosaminidase kit. By implementing the amendment we want to examine and determine the validity of surrogate renal damage biomarkers i.e. urine cytokines and the miRNA complement of exosomes. In addition, we would like to identify miRNA biomarkers in the plasma that indicate responsiveness to cisplatin. | — |
Countries
Netherlands
Outcome results
None listed