A study that investigates whether short hydration is a better option to prevent kidney damage than long hydration during cisplatin chemotherapy in patients with head and neck cancer.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003890-23-NL

Enrollment

226

Registered

2021-02-19

Start date

2021-02-23

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Cisplatin induced nephrotoxicity

Interventions

Trade Name: Cisplatin 1 mg/ml Concentrate for Solution for Infusion Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Cisplatin CAS Number: 15663-27-1 Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the incidence of cisplatin induced nephrotoxicity during 7 weekly cycles of cisplatin (40mg/m2) chemotherapy in patients with head and neck cancer using a long hydration-scheme compared to patients using a short hydration scheme.;Secondary Objective: To examine the average change in serum creatinine during the various timepoints at which sCr is measured during this trial as per protocol relative to baseline sCr. To examine the amount of cisplatin cycles administered in both treatment arms. To examine incidence of hospitalization due to chemotherapy related toxicity. To examine the reasons for discontinuing cisplatin chemotherapy. To examine the incidence of the separate grades of creatinine increased according to baseline criteria according CTCAE v5.0. To examine the incidence of the separate grades of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0. To examine the incidence of Acute Kidney Injury any grade according to CTCAE v4.0, RIFLE and KDIGO criteria To examine the incidence of chronic kidney disease (CKD) any grade according to KDIGO criteria three months after the last cisplatin cycle. ;Primary end point(s): The primary endpoint in this trial is the incidence of nephrotoxicity. Nephrotoxicity is expressed as the incidence of creatinine increased grade =2 according to CTCAE v5.0;Timepoint(s) of evaluation of this end point: During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The primary endpoint will be evaluated at each of these timepoints.	—

Measure

Time frame

Main Objective: To compare the incidence of cisplatin induced nephrotoxicity during 7 weekly cycles of cisplatin (40mg/m2) chemotherapy in patients with head and neck cancer using a long hydration-scheme compared to patients using a short hydration scheme.;Secondary Objective: To examine the average change in serum creatinine during the various timepoints at which sCr is measured during this trial as per protocol relative to baseline sCr. To examine the amount of cisplatin cycles administered in both treatment arms. To examine incidence of hospitalization due to chemotherapy related toxicity. To examine the reasons for discontinuing cisplatin chemotherapy. To examine the incidence of the separate grades of creatinine increased according to baseline criteria according CTCAE v5.0. To examine the incidence of the separate grades of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0. To examine the incidence of Acute Kidney Injury any grade according to CTCAE v4.0, RIFLE and KDIGO criteria To examine the incidence of chronic kidney disease (CKD) any grade according to KDIGO criteria three months after the last cisplatin cycle. ;Primary end point(s): The primary endpoint in this trial is the incidence of nephrotoxicity. Nephrotoxicity is expressed as the incidence of creatinine increased grade =2 according to CTCAE v5.0;Timepoint(s) of evaluation of this end point: During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The primary endpoint will be evaluated at each of these timepoints.

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Secondary

Measure	Time frame
Secondary end point(s): - The average change in serum creatinine between baseline serum creatinine and serum creatinine measured throughout the study as per protocol. Change in serum creatinine will be described both absolute and percentagewise. - Amount of cisplatin cycles administered in both treatment arms. - Incidence of hospitalization due to chemotherapy related toxicity. - Reason for discontinuing cisplatin treatment in the ShortCis trial. - The incidence of creatinine increased any grade according to baseline criteria according CTCAE v5.0. - The incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0. Incidence of AKI any grade according to CTCAE v4.0. - Incidence of acute kidney injury according to RIFLE criteria. - Incidence of acute kidney injury according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline criteria for Acute Kidney Injury (AKI). - The incidence of CKD any grade according to KDIGO criteria measured 3 months after last dose of cisplatin. ;Timepoint(s) of evaluation of this end point: Secondary end points will be measured and evaluated during the trial as per protocol. During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The secondary endpoints that relate to sCr values and renal function will be evaluated at each of these timepoints. The incidence of CKD will be evaluated at 3 months after the last cisplatin cycle.	—

Measure

Time frame

Secondary end point(s): - The average change in serum creatinine between baseline serum creatinine and serum creatinine measured throughout the study as per protocol. Change in serum creatinine will be described both absolute and percentagewise. - Amount of cisplatin cycles administered in both treatment arms. - Incidence of hospitalization due to chemotherapy related toxicity. - Reason for discontinuing cisplatin treatment in the ShortCis trial. - The incidence of creatinine increased any grade according to baseline criteria according CTCAE v5.0. - The incidence of creatinine increased any grade according to Upper Limit of Normal (ULN) criteria according CTCAE v5.0. Incidence of AKI any grade according to CTCAE v4.0. - Incidence of acute kidney injury according to RIFLE criteria. - Incidence of acute kidney injury according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline criteria for Acute Kidney Injury (AKI). - The incidence of CKD any grade according to KDIGO criteria measured 3 months after last dose of cisplatin. ;Timepoint(s) of evaluation of this end point: Secondary end points will be measured and evaluated during the trial as per protocol. During this trial sCr values will be measured throughout the trial as per protocol. From the second cycle of cisplatin onward sCr shall be measured and evaluated prior to cisplatin chemotherapy on the day of cisplatin chemotherapy. The secondary endpoints that relate to sCr values and renal function will be evaluated at each of these timepoints. The incidence of CKD will be evaluated at 3 months after the last cisplatin cycle.

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Countries

Netherlands

Contacts

Public ContactR. Malmberg

Erasmus MC Cancer Institute

r.malmberg@erasmusmc.nl00310107033202

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026