Acute kidney injury in head and neck cancer patients recieving ORS compare with patients receiving only conventional therapy during treatment with high dose cisplatin concurrently with radiation. CCRT with high dose cisplatin nephrotoxicity oral rehydration solution prevention cisplatin induced nephrotoxicity
Conditions
Interventions
the patients received 2000 ml of oral rehydration solution ( ORS) 24 hr before and on day 2 and 3 after chemotherapy along with short hydration therapy (2000 ml of normal saline infusion in 1 hr prior
Oral rehydration solution,Convention therapy
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with head and neck cancer, confirmed by histopathology. 2. Receiving high dose cisplatin ( >= 50 mg/m2) concurrent with radiation therapy. 3. ECOG 0-2 4. Age >= 18 years old 5. Normal renal function (creatinine clearance, ≥50 mL/min) 6. Acceptable blood chemistry level Potassium >= 3 mmol/L , Ca >= 7 mg/dl, Magnesium >= 0.9 mg/dl and all need to corrected into normal range before initiating cisplatin 7. Adequate hematologic function :ANC > 1,500 mm3, platelet >= 100,000 mm3, Hb >= 8 g/dl 8. Adequate hepatic fucntion : AST, ALT <= 2 times of UNL 9. Capability to adhere to dietary constraints and consume ≥ 2000 mL of water per day ( both orally and via feeding tube). 10. No prolongation of QT interval from baseline ECG ( <= 460 msec in female and <= 440 msec in male) 11. Already signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled of serious medical-comorbidities 2. Uncontrolled diabetes millitus ( FBS at screening date >= 180 mg/m2 or HbA1C more than 8% in the past 3 months 3. Serum sodium lower than 130 mmol/L 4. History of heart failure, cardiomyopathy or coronary artery disease in the past 1 year. 5. Currently using other nephrotoxic agents such as gentamicin , amikacin or NSAIDs ( except low dose aspirin) 6. Preexisting hearing problem that not relevant to cancer. 7. Preexisting significant neuropathy 8. Currently enter in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Creatinine elevation at Day 8 after cisplatin cycle 1 at C1D8 cisplatin Serum creatinine | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine elevation at Day 90 after cisplatin cycle 1 at Day 90 after C1 cisplatin Serum creatinine,Risk factor of nephrotoxicity in patients who received CCRT with high dose cisplatin Assess in every visit Blood chemistry, patient history,Quality of life in patients who received CCRT with high dose cisplatin Assess at C1D1, C1D8, C1D15 and Day 90 Questioniares ( FACT-G),Response rate 8-16 weeks after complete CCRT CT scan measurement by RECIST criteria | — |
Countries
Thailand
Contacts
Public ContactAungsumal Maisrikrod
Faculty of Medicine, Prince of Songkla University
Outcome results
None listed