Clinical trial NCT06491082: Chemotherapy Induced Neuropathy in Cancer Patients
Official title: Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy induced Neuropathy
NADPH oxidase 4
25-Hydroxy Vitamin D
Homocysteine
Vitamin B12
Proteomics profiling
Quality of Life
Lead sponsor: Swami Rama Himalayan University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stage I-IV Solid Cancer who will receive Cisplatin or Carboplatin or paclitaxel or docetaxel as part of their standard

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.

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

Primary outcomes:
measure: Assessment of different type and severity of Neuropathy in Solid Cancer Patients Undergoing Chemotherapy using Total Neuropathy Score(TNS) and Nerve conduction velocity study
timeFrame: Baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days
measure: NOX4 Gene Expression in Blood of Solid Cancer Patients Undergoing Chemotherapy
timeFrame: at Baseline and after 4th cycle of chemotherapy (3weekly cycle) 84 days
measure: Serum Vitamin D and Homocysteine Levels in Solid Cancer Patients Undergoing Chemotherapy
timeFrame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days
measure: serum catalase and malondialdehyde level in solid cancer patients undergoing chemotherapy
timeFrame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
measure: Nerve conduction studies (NCS)
timeFrame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Secondary outcomes:
measure: Measures peripheral neuropathy grade and quality of life using EORTC-QLQ-CIPN20
timeFrame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Other outcomes:
Locations:
city: Dehradun
country: India
facility: Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences
Study officials:
References: