Short hydration during cisplatin chemo radiation is significantly more effective than long hydration in preventing acute kidney injury
ID
Bron
Verkorte titel
Aandoening
Head and neck cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Creatinine Increased grade 2 or higher (baseline criteria) according to CTCAE v5.0
Achtergrond van het onderzoek
Cisplatin based chemotherapy is frequently used in the treatment of head and
neck cancer patients. Although highly effective cisplatin efficacy is often limited by toxicity.
Cisplatin induced nephrotoxicity (CIN) remains the main dose limiting toxicity despite
numerous preventive interventions, like extensive hydration prior- and post cisplatin infusion.
Its efficacy in reducing CIN is well established (1), although the optimal duration of hydration
is still debated. According to the SPC of cisplatin patients receiving cisplatin should receive
hydration pre- and post-hydration for a total of 12-24 hours (2).
During the last decades numerous publications have reported about the feasibility of shorter
hydration schemes (4-6 hours) during cisplatin chemotherapy (3-9). Some publications have
even shown that short hydration (SH) during cisplatin chemotherapy might even be more
effective in preventing nephrotoxicity than long hydration (LH) (10-14). Most of these
publications are however limited by their design as they consist of non-randomized single
arm studies, retrospective studies or prospective studies with historical controls. Data from
randomized controlled clinical trials are still lacking. Despite this limited evidence, SH
schemes are increasingly adopted as part of standard of care cisplatin treatment. This is
because SH has considerable advantages over LH as it could shorten patients stay in
hospital and enable outpatient instead of inpatient treatment. This could lead to reduced
treatment burden for patients, optimized quality of life and reduced healthcare costs. In order
to establish the nephroprotective superiority of SH over LH a prospective, open label,
randomized controlled trial will be conducted.
Doel van het onderzoek
Short hydration during cisplatin chemo radiation is significantly more effective than long hydration in preventing acute kidney injury
Onderzoeksopzet
Baseline screening 1st cycle 2nd cycle 3rd cycle 4th cycle 5th cycle 6th cycle 7th cycle Last study visit (3 months after last cycle)
Medical history X
In- / exclusion criteria X
Provide Information about the study X
Written informed consent X
Hematology and blood chemistry X X X X X X X X
Urine sample collection X X X X X X X X
Cisplatin chemotherapy X X X X X X X
Onderzoeksproduct en/of interventie
Short hydration protocol during cisplatin chemo radiation
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age ≥18 years;
All patients with diagnosed head and neck cancer with a standard of care indication
for chemo radiation with weekly cisplatin 40 mg/m2 (CHEMORAD) treatment.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Prior treatment with cisplatin.
Unable to give written informed consent according to the International Council for
Harmonisation-Good clinical practice (ICH-GCP) and national / local regulations
Opzet
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Register | ID |
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NTR-new | NL9291 |
Ander register | METC EMC : METC 2020-0925 |