Evalution of oral nano-curcumin formulation efficacy in prevention of cisplatin induced nephrotixicity in cancer patients

Evalution of oral nano-curcumin formulation efficacy in prevention of cisplatin induced nephrotoxicity in cancer patients.

The clinical trial has a control group with parallel groups, triple blinded, randomized, phase 2 on 30 patients. Randomization.com site was used for randomization.

30 patients aged 18-60 with cancers referred to the Oncology and Radiotherapy Clinic of Imam Reza, who met the inclusion criteria.Patients are randomly assigned to the placebo or drug.The chemotherapy regimen of all patients contains cisplatin at the rate of 40 mg/m2 per week.

To enter the study:Chemotherapy regimen cisplatin dose of 70mg/m2 every three weeks or 40mg/m2 weekly, Age above 18 years and below 70 years, GFR>60 ml/min, Normal liver function, Normality of patients' CBC Not entering the study:Allergy to curcumin, Patient dissatisfaction, Reduction of patient's GFR below 45ml/min during treatment, Receiving other nephrotoxic drugs such as aminoglycosides, amphotericin, vancomycin-Chronic heart failure EF<60%, Untreated hypothyroidism or hyperthyroidism Active infection, Receiving anti-inflammatory and antioxidant drugs at the same time Unfavorable health status (PS<70%) based on karnofsky index.

intervention group:two capsules of cinacorcumin 40 mg are prescribed for six chemotherapy courses.in the control group, two placebo capsules are prescribed per day that are filled with cinacorcumin carrier with the same appearance as the original drug.

Serum creatinine and BUN levels will be recorded at the beginning of the study. The patient's kidney status will be evaluated every three weeks at the same time as the chemotherapy courses based on serum creatinine and BUN levels.

Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo.

Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Data collection and analysis will be performed by the clinical pharmacy resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.