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Curcumin supplementation in cancer patients under cisplatin treatment

Evaluation of the effects of curcumin supplementation on oxidative stress indices in patients treated with cisplatin: a double-blind, placebo-controlled randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190305042939N2
Enrollment
50
Registered
2022-07-14
Start date
2022-07-23
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Cancer types. Malignant neoplasm of ovary, Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group Patients with malignancy who will receive cisplatin with the dose 50-100 mg/m2 will be identified and after signing the consent will be considered for intervention.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with malignancy who receive cisplatin for the first time in their treatment regimens GFR higher than 60 mL/min based on CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) The patient be able to receive curcumin orally

Exclusion criteria

Exclusion criteria: Patients with active infection or symptoms of sepsis Patients who have received nephrotoxic drugs such as aminoglycoside, amphotericin, vancomycin, colistin, media contrast, calcineurin inhibitors or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for the past 72 hours Patients who have a history of taking cisplatin Patients who may experience complications or allergic reactions to curcumin during treatment Patients who had a history of acute kidney injury ( AKI ) before entering the study The patient's unwillingness to cooperate during the research Patients with bilirubin above 2 mg / dl or liver enzymes above 2.5 times the normal level

Design outcomes

Primary

MeasureTime frame
Total antioxidant capacity: A set of compounds that are able to protect biological systems against the harmful effects of reactive oxygen and nitrogen species . Timepoint: Baseline and End-of-trial. Method of measurement: Total antioxidant capacity testing is performed through commercially available kits and the ELISA reader.;Malondialdehyde (MDA): One of the most common lipid indicators of oxidative stress. Timepoint: Baseline and End-of-trial. Method of measurement: Serum malondialdehyde levels are assessed through commercially available kits and an ELISA reader.;Activity of catalase enzyme: It is an antioxidant enzyme involved in the detoxification of hydrogen peroxide (the reactive oxygen species). Timepoint: Baseline and End-of-trial. Method of measurement: Catalase activity is assessed through commercially available kits and an ELISA reader.;Activity of super oxide dismutase enzyme: It is an enzyme that converts superoxide free radicals to hydrogen peroxide and oxygen molecules. Timepoint: Baseline and End-of-trial. Method of measurement: super oxide dismutase activity is assessed through commercially available kits and an ELISA reader.

Secondary

MeasureTime frame
Expressed levels of interleukin-6 gene. Timepoint: Baseline and End-of-trial. Method of measurement: We first synthesize RNA molecules with the help of reverse transcriptase enzyme (MMLV enzyme) and convert them into complementary DNAs called cDNAs. Then, with the help of Realtime PCR, we examine the expression of the target gene.;Expressed levels of NRF-2 gene. Timepoint: Baseline and End-of-trial. Method of measurement: We first synthesize RNA molecules with the help of reverse transcriptase enzyme (MMLV enzyme) and convert them into complementary DNAs called cDNAs. Then, with the help of Realtime PCR, we examine the expression of the target gene.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadhosein Araabi

Esfahan University of Medical Sciences

mh.aarabi@pharm.mui.ac.ir+98 31 3792 7052

Outcome results

None listed

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