Chemotherapy Induced Neuropathy in Cancer Patients
NCT Number: NCT06491082
Acronym: CIN
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chemotherapy-induced Peripheral Neuropathy
Interventions: DRUG: Cisplatin, Carboplatin, Paclitaxel, Docetaxel
Sponsor: Swami Rama Himalayan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-23
Completion Date: 2024-08-25
Locations: Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences, Dehradun, 248016, India

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.

Primary Outcome Measures: Assessment of different type and severity of Neuropathy in Solid Cancer Patients Undergoing Chemotherapy using Total Neuropathy Score(TNS) and Nerve conduction velocity study, Sensory symptoms, Motor Symptoms, Pin sensation, Vibration sensibility, Strength, Tendon reflexes will be recording using likert scale from 0 to 5 "0= None, 1= Limited to fingers or toes, 2= Extend to ankle or wrist, 3= Extend to knee or elbow, 4= Above knees/elbows"., Baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days|NOX4 Gene Expression in Blood of Solid Cancer Patients Undergoing Chemotherapy, The expression level of the NADPH oxidase 4 (NOX4) gene in blood will be measured using real time polymerase chain reaction (RT-PCR) to assess its potential role in chemotherapy-induced neuropathy. Ct-value of Nox4 gene will be normalized with reference gene GAPDH to calculate relative expression using 2-∆∆Ct method. Changes in NOX4 expression will be analyzed to understand its relationship with neuropathy development in solid cancer patients undergoing chemotherapy. Blood samples will be collected at baseline and after the fourth cycle of chemotherapy, at Baseline and after 4th cycle of chemotherapy (3weekly cycle) 84 days|Serum Vitamin D and Homocysteine Levels in Solid Cancer Patients Undergoing Chemotherapy, Serum levels of vitamin D and homocysteine will be measured using chemiluminescent immunoassay (CLIA) techniques to evaluate their potential association with chemotherapy-induced neuropathy. Vitamin D plays a role in nerve health, while elevated homocysteine levels have been linked to nerve damage. These biomarkers will be assessed to explore their correlation with neuropathy symptoms. Blood samples for vitamin D and homocysteine levels will be collected at baseline and after the fourth cycle of chemotherapy., at baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days|serum catalase and malondialdehyde level in solid cancer patients undergoing chemotherapy, Catalase and Malondialdehyde will be measured using Enzyme linked immunosorbent assay (ELISA) to determine oxidative stress status., at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)|Nerve conduction studies (NCS), * Sensory nerve studies: Median and ulnar nerve measurements like the amplitude (mV), conduction velocity (m/s) and distal latency (ms) will be recorded at wrist and interpretation will be done as demyelination when amplitude decreases or normal, velocity- decreases and Latency-increases; Axonal when amplitude-decreased, conduction velocity-normal and latency normal
* Motor nerve studies: Median and ulnar nerve measurements like the amplitude (mV), conduction velocity (m/s) and distal latency (ms) will be recorded at wrist and elbow and interpretation will be done as demyelination when amplitude decreases or normal, velocity- decreases and Latency-increases; Axonal when amplitude-decreased, conduction velocity-normal and latency normal, at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Secondary Outcome Measures: Measures peripheral neuropathy grade and quality of life using EORTC-QLQ-CIPN20, Chemotherapy-induced Peripheral Neuropathy 20 items" (EORTC-QLQ-CIPN20)) and analysis of clinical decision-making to assess the incidence, severity and interference of peripheral neuropathy. Scale of EORTC-QLQ-CIPN20: assess 20 items (sensory (9), motor (8), autonomic symptoms (3)) with the use of a 4-point Likert scale (1 = "Not at all", 2 = "A little", 3 = "Quite a bit", 4 = "Very much", at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)