Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491082
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-15
Brief Title:
Chemotherapy Induced Neuropathy in Cancer Patients
Sponsor:
Swami Rama Himalayan University
Organization:
Swami Rama Himalayan University
Study Overview
Official Title:
Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIN
Brief Summary:
The purpose of this prospective study is to perform Nerve conduction test Vitamin D Vitamin B12 and NADPH oxidase 4NOX4 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:
AScreening 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 403
BEstimation of 125-dihydroxyvitamin-D and Homocysteine level in all groups at baseline 4th cycle 1016 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
DTotal Reactive oxygen species ROS by conventional Catalase and D-ROMsreactive oxygen metabolites test in all groups at baseline 4th cycle EProteomic 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
BEstimation of 125-dihydroxyvitamin-D and Homocysteine level in all groups at baseline 4th cycle 1016 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
DTotal Reactive oxygen species ROS by conventional Catalase and D-ROMsreactive oxygen metabolites test in all groups at baseline 4th cycle EProteomic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None