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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin, Carboplatin, Paclitaxel, Docetaxel | Drug | Solid cancer Patients receiving any one drug or in combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Stage I-IV Solid Cancer who will receive Cisplatin or Carboplatin or paclitaxel or docetaxel as part of their standard
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences | Recruiting | Dehradun | 248016 | India |
This will be done later with permission from research board
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days) |
| Nerve conduction studies (NCS) |
| at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days) |
| at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days) |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |