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NCT Number: NCT06491082

Chemotherapy Induced Neuropathy in Cancer Patients

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Dehradun, 248016, India

Location status: Recruiting

Location contact

Deepak Goel, Neurology

SUB_INVESTIGATOR

Dilip C. Dhasmana, Pharmacology

SUB_INVESTIGATOR

Juhi Kalra, MD Pharmacology

CONTACT

[email protected]

7505147054

Juhi Kalra, Pharmacology

SUB_INVESTIGATOR

Nabin K. Yadav, Pharmacology

PRINCIPAL_INVESTIGATOR

Nabin Yadav, PhD Pharmacology

CONTACT

[email protected]

8887604699

Vipul Nautiyal, Radiation Oncology

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin, Carboplatin, Paclitaxel, Docetaxel

Drug

Solid cancer Patients receiving any one drug or in combination

Primary outcomes

  1. Assessment of different type and severity of Neuropathy in Solid Cancer Patients Undergoing Chemotherapy using Total Neuropathy Score(TNS) and Nerve conduction velocity study

    Time frame: Baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days

    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".

  2. NOX4 Gene Expression in Blood of Solid Cancer Patients Undergoing Chemotherapy

    Time frame: at Baseline and after 4th cycle of chemotherapy (3weekly cycle) 84 days

    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

  3. Serum Vitamin D and Homocysteine Levels in Solid Cancer Patients Undergoing Chemotherapy

    Time frame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days

    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.

  4. serum catalase and malondialdehyde level in solid cancer patients undergoing chemotherapy

    Time frame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)

    Catalase and Malondialdehyde will be measured using Enzyme linked immunosorbent assay (ELISA) to determine oxidative stress status.

  5. Nerve conduction studies (NCS)

    Time frame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)

    • 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

Secondary outcomes

  1. Measures peripheral neuropathy grade and quality of life using EORTC-QLQ-CIPN20

    Time frame: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)

    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"

Sponsors and collaborators

Lead sponsor

Swami Rama Himalayan University

Other

Registry information

Official study title

Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients

Acronym: CIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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