NCT06491082

Chemotherapy Induced Neuropathy in Cancer Patients

Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 124 (estimated)
• Sponsor: Swami Rama Himalayan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this prospective study is to perform Nerve conduction test, Vitamin D, Vitamin B12 and NADPH oxidase 4(NOX4) expression to assess severity of chemotherapy induced Peripheral neuropathy (CIPN) in solid cancer (Head and Neck, Breast, Prostate) patients who planned for at least 4 cycle of chemotherapy in different nutrient status level and gene expression.

Detailed description

A)Screening of neuropathy in Healthy subject and Solid cancer patient before receiving chemotherapy \& after 4th cycle of chemotherapy Patient who will be included in this study undergo complete neurological examination by using Total neuropathy score clinical version and Nerve conduction velocity test at baseline (0-cycle). Patients with no signs and symptoms of neuropathy will be recruited for the study. They will be followed up during the course of treatment and will undergo complete neurological examination by Total neuropathy score clinical version and nerve conduction velocity test will be done at 4th cycle to detect CIPN. Severity of CIPN will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. B)Estimation of 1,25-dihydroxyvitamin-D and Homocysteine level in all groups at baseline \& 4th cycle 10,16 Approximately five millilitre of peripheral venous blood will be collected from each patient in anticoagulant (Acid-citrate-dextrose A) and centrifuge at 2500 RPM for 5 minutes. The plasma will be transferred to another tube remaining cell content will be discarded \&the plasma will be stored at -20 degree Celsius. The estimation of Concentration 1, 25-hydroxyvitamin-D and Homocysteine using CLIA. The entire sample will be analysed following quality control analysis to eliminate error. C) Measurement of NOX4 gene expression by RT-PCR (Real Time Polymerase Chain Reaction) analysis in all groups at baseline \& 4th cycle * To measure expression of NOX4 gene during treatment with and without neuropathy. * Total RNA will be extracted from blood by using Himedia RNA isolation kit and then * The cDNA will be amplified using cDNA synthesis kit (Himedia). The cDNAs will be subjected to RT-PCR analysis using Himedia mastermix with primer sets and Housekeeping gene GAPDH. D)Total Reactive oxygen species (ROS) by conventional Catalase and D-ROMs(reactive oxygen metabolites) test in all groups at baseline \& 4th cycle E)Proteomic profile by Liquid Chromatography-Mass Spectroscopy in all groups at baseline \& 4th cycle. The cellular and mitochondrial protein post translational modification increase production of ROS. F) Evaluation of Quality of life by using EORTC-QLQ -CIPN20 Questionnaire in all groups at baseline \& 4th cycle. The patient who are undergoing chemotherapy will be asked questions from questionnaire in their local language while waiting in outpatient department of Radiation oncology department at baseline and 4 cycle.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Cisplatin, Carboplatin, Paclitaxel, Docetaxel	Solid cancer Patients receiving any one drug or in combination

Timeline

• Start date: 2022-11-23
• Primary completion: 2024-08-20
• Completion: 2024-08-25
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study