Investigating the effect of oral Curcumin on vincristine-induced neuropathy in children with Acute lymphoblastic leukemia

To determine the effect of oral Curcumin compared to placebo on vincristine-induced neuropathy in children with ALL

Randomized clinical trial with parallel groups, double-blind, phase 3 on 140 patients. Randomization was done using the block randomization method and the website www.sealedenvelope.com.

The study was conducted in the hematology and oncology ward of Ali Asghar children's Hospital in Tehran. The patients in the intervention and placebo groups were undergo the intervention for 3 months, and both groups examined in terms of the neuropathy until the end of the third month from the start of the intervention. Patients, clinical care providers and outcome assessors were blinded in this study.

Inclusion criteria: Children aged 5-18 years who have recently been diagnosed with ALL and have not yet started treatment with Vincristine Exclusion criteria: Congenital malformations and developmental disoreders, Primary central nervous system involvement, History of taking anti-inflammatory and antioxidant drugs, Under treatment with other drugs leading to nephropathy, Presence of neuropathy before treatment with vincristine

Intervention group: Patients received one oral capsule of Curcumin every 12 hours (with a dose of 3 mg/kg) for 3 months. Placebo group: Patients received a placebo tablet (with same packaging and color as Curcumin) every 12 hours for 3 months.

Presence or absence of neuropathy; Severity of neuropathy

In this study, the Block Randomization method was used using block size of 6 and 4 . The website https://www.sealedenvelope.com was used to generate random sequences. For the sequence concealment, it was given to an independent individual and was revealed case by case and with unique codes to the main researcher of the study.

Patient blinding method: Since the Curcumin drug is in the form of a capsule, for the similarity of the shape, we put a placebo in the form of powder inside the curcumin-shaped capsule so that both drugs look identical. Method of blinding the doctor: The sealed medicine envelopes were given to a researcher who had no involvement in choosing the type of medicine. After the subjects entered the study and their baseline information was collected by the doctor, they went to the researcher to get medicine, and the researcher gave one of the envelopes to the patients. A unique code was written on each envelope.