Chemotherapy Induced Neuropathy in Cancer Patients

NCT ID: NCT06491082

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2024-08-25

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Baseline and after 4th cycle

Histopathologically diagnosed Solid Cancer Patients Planned for Platinum and Taxane based chemotherapy will be going for Neuropathy test- Nerve conduction test(NCV), vitamin D, B12 and Nox4 expression at Baseline and after 4th cycle of chemo

Cisplatin, Carboplatin, Paclitaxel, Docetaxel

Intervention Type: DRUG

Solid cancer Patients receiving any one drug or in combination

Interventions

Cisplatin, Carboplatin, Paclitaxel, Docetaxel

Solid cancer Patients receiving any one drug or in combination

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients receiving chemotherapy for solid cancer
• Patient aged>18years

Exclusion Criteria

• Age ≤ 18 years
• Pre-existing neuropathy
• Patients diagnosed with Psychiatric illness
• Patients with pre-existing peripheral neuropathy
• Patients taking medication for neuropathy
• Long standing diabetes (>10 years)
• Renal and Hepatic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swami Rama Himalayan University

OTHER

Sponsor Role: lead

Responsible Party

Nabin Yadav

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences

Dehradun, , India

Site Status: RECRUITING

Countries

India

Facility Contacts

Nabin Yadav, PhD Pharmacology

Role: primary

nabinapsyadav8@gmail.com

8887604699

Juhi Kalra, MD Pharmacology

Role: backup

juhikalra@srhu.edu.in

7505147054

Other Identifiers

SRHU2022386

Identifier Type: -

Identifier Source: org_study_id