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Curcumin effects on the prevention of peripheral neuropathy-induced by chemotherapy regimen containing paclitaxel in breast cancer patients; a randomized, double blinded and placebo-controlled clinical trial

Curcumin effects on the prevention of peripheral neuropathy-induced by chemotherapy regimen containing paclitaxel in breast cancer patients; a randomized, double blinded and placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180722040556N10
Enrollment
60
Registered
2024-01-28
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-03-06

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

Conditions

Breast cancer patients. (C50-C50)

Interventions

Intervention 1: In the intervention group, patients received 40 mg nanocurcumin capsules three times a day for 2 months. Intervention 2: in placebo group, patients use nanocurcumin drug placebo three

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All adult women (18 years and older and less than 65 years old) with non-metastatic breast cancer who received paclitaxel at a dose of 175 mg/m2 every 3 weeks for 4 courses after completing an anthracycline-containing regimen for the first time in the treatment process (New case patients). The patient must have compliance in taking medication for at least 8 weeks and have enough ability to swallow and consume nanocurcumin capsules orally. Patients should have the necessary literacy to fill in the questionnairesand also have the necessary cooperation in performing neurological tests. Patients who do not have any history of liver and kidney failure.

Exclusion criteria

Exclusion criteria: Patients with a history of any peripheral neuropathy Patients with a history of coronary artery disease and peripheral vascular disease All diabetic patients Pregnancy and breastfeeding taking anticonvulsant drugs, Tricyclic antidepressants, other neuropathic pain relievers such as duloxetine Chronic use of cigarettes, drugs or alcohol Patients with a history of peripheral neuropathy (eg, hereditary, with nutritional factors and paraneoplastic causes) Those who have received chemotherapy for another malignancy in the past. Metastasis to the central nervous system or any neurological involvement due to metastasis or tumor pressure Users of anti-platelet drugs such as aspirin, etc. and oral and injectable anti-thrombosis

Design outcomes

Primary

MeasureTime frame
Determining and comparing the severity of neuropathy before and after the intervention in each of the intervention and placebo groups. Timepoint: Before the start of chemotherapy - before the second cycle of chemotherapy - before the third cycle of chemotherapy. Method of measurement: Determining and comparing the mean score of NSS, NDS and MNSI index, and comparing neurological tests before and after the intervention.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh moghaddas

Esfahan University of Medical Sciences

moghaddas@pharm.mui.ac.ir+98 31 3792 7074

Outcome results

None listed

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