The nephroprotective effect of short hydration during cisplatin treatment in head and neck cancer patients.

The nephroprotective effect of short hydration during cisplatin treatment in head and neck cancer patients. - Shortcis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50989

Enrollment

226

Registered

2021-02-16

Start date

2021-03-04

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney damage Nephrotoxicity

Interventions

Patients will receive standard care cisplatin chemo radiation therapy. Prior to treatment, patients will be randomized over an arm in which the cisplatin is administered using a long hydration regim

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years; - Newly diagnosed head and neck cancer with a standard of care indication for cisplatin 40 mg/m2 Q1W chemo radiation treatment - Written informed consent according to the International Council for Harmonisation-Good clinical practice (ICH-GCP) and national / local regulations - Ability to return to the Erasmus MC Cancer Institute for adequate follow-up

Exclusion criteria

Exclusion criteria: - Prior treatment with cisplatin. - The presence of clinically relevant drug interactions according to the current SmPC - The presence of clinically relevant contra-indications according to the current SmPC - Hypersensitivity towards cisplatin or any of the excipients - Pregnancy or lactation - Chronic kidney disease - Baseline eGFR

Design outcomes

Primary

Measure	Time frame
The incidence acute kidney injury (AKI) grade >= 1 according to CTCAE v4.0 criteria during cisplatin 40mg/m2 Q1W chemo radiation in patients with head and neck cancer using a long hydration scheme compared to patients using a short hydration scheme.	—

Secondary

Measure	Time frame
- To examine the incidence of AKI grade 1, grade 2, grade 3, grade 4 and grade 5 according to CTCAE v4.0 - To examine the incidence of AKI according to RIFLE criteria and KDIGO criteria - To examine the incidence of creatinine increased any grade according to baseline criteria according CTCAE v4.0 - To examine the incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v4.0 - To examine the incidence of chronic kidney disease (CKD) any grade according to CTCAE v4.0 six months after the last cisplatin cycle - To examine the change in eGFR due to cisplatin chemo radiation. By examining the difference in eGFR (CKD-EPI) before cisplatin treatment (pre-treatment eGFR) and the eGFR after the last cisplatin cycle (post-treatment eGFR) - To examine the effect of hydration duration on the relative dose intensity of administered cisplatin. - To examine the safety of a short hydration scheme by examining the incidence of hospitalizatons	—

Measure

Time frame

- To examine the incidence of AKI grade 1, grade 2, grade 3, grade 4 and grade 5 according to CTCAE v4.0 - To examine the incidence of AKI according to RIFLE criteria and KDIGO criteria - To examine the incidence of creatinine increased any grade according to baseline criteria according CTCAE v4.0 - To examine the incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v4.0 - To examine the incidence of chronic kidney disease (CKD) any grade according to CTCAE v4.0 six months after the last cisplatin cycle - To examine the change in eGFR due to cisplatin chemo radiation. By examining the difference in eGFR (CKD-EPI) before cisplatin treatment (pre-treatment eGFR) and the eGFR after the last cisplatin cycle (post-treatment eGFR) - To examine the effect of hydration duration on the relative dose intensity of administered cisplatin. - To examine the safety of a short hydration scheme by examining the incidence of hospitalizatons

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)