A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

The study will be conducted at four major medical centers, including the University of
Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the
MD Anderson Cancer Center. Blood and urine samples will be collected from patients
undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs
known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common
chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common
antibiotic drug taken by patients with cystic fibrosis.

Inclusion Criteria (Cisplatin Treatment Group):

1. Males and females ≥ 18 years of age

2. Diagnosis of head & neck cancer and confirmation that patient is due to receive a 1st
cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

- as single agent chemotherapy in conjunction with local radiotherapy course, or

- as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)

3. Willingness and ability to comply with study procedures and study restrictions

4. Ability to provide written informed consent

Inclusion Criteria (Control Group):

1. Males and females ≥ 18 years of age

2. Diagnosis of head & neck cancer or similar condition such as an upper body, localised
malignancy. These control patients will be scheduled to receive a non-nephrotoxic
treatment modality (e.g. local radiotherapy alone)

3. Willingness and ability to comply with study procedures and study restrictions

4. Ability to provide written informed consent

Exclusion Criteria (All Subjects):

1. Chronic kidney disease defined by eGFR <60 mL/min/1.73m2. Patients with normal eGFR
but persistent dipstick proteinuria require urinary albumin measurement: those with
microalbuminuria (>30 mcg/mg creatinine) will be excluded

2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use
of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous
vancomycin, or ACEi)

3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month

4. Patients currently receiving trimethoprim or cimetidine or other medications known to
alter the tubular secretion of creatinine

5. Use of creatine supplements within 7 days prior to hospitalization

6. Solid organ transplant recipients

7. Abnormal liver function (serum ALT, AST or total bilirubin >2xULN)

8. Significant anemia (Hemoglobin < 10 g/dL)

9. Pregnancy

10. Institutionalized individuals