Chemotherapy-induced Peripheral NeuropathyCINNCT06491082
Chemotherapy Induced Neuropathy in Cancer Patients
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Swami Rama Himalayan University at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Cisplatin, Carboplatin, Paclitaxel, Docetaxel
- How many people
- 124 participants
- Where
- 1 siteIndia
- Study dates
- 23 Nov 2022to 25 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Stage I-IV Solid Cancer who will receive Cisplatin or Carboplatin or paclitaxel or docetaxel as part of their standard
Who may be able to join
- All patients receiving chemotherapy for solid cancer
- Patient aged>18years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences
Dehradun, 248016
Nabin Yadav, PhD Pharmacology, 8887604699, nabinapsyadav8@gmail.com
Juhi Kalra, MD Pharmacology, 7505147054, juhikalra@srhu.edu.in
About this study
Official title: Evaluation of Chemotherapy Induced Neuropathy in Solid 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.
Read the 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.
- 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.
- 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.
- Being tested
- Cisplatin, Carboplatin, Paclitaxel, Docetaxel
- Keywords
- Chemotherapy induced Neuropathy, NADPH oxidase 4, 25-Hydroxy Vitamin D, Homocysteine, Vitamin B12, Proteomics profiling, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin, Carboplatin, Paclitaxel, DocetaxelDrug
Solid cancer Patients receiving any one drug or in combination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cisplatin, Carboplatin, Paclitaxel, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Secondary outcomes (1)
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"
Measured: at baseline and after 4th cycle of chemotherapy ( 3weekly cycle= 84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start23 Nov 2022
- Primary completion20 Aug 2024 (estimated)
- Study completion25 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swami Rama Himalayan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabin Yadav, Swami Rama Himalayan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491082
- Sponsor's protocol ID
- SRHU2022386
- Acronym
- CIN
- Status last verified
- Jul 2024
- First submitted
- 15 Mar 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be done later with permission from research board
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chemotherapy Induced Neuropathy in Solid Cancer Patients
- ClinicalTrials.gov ID
- NCT06491082
- Acronym / sponsor ID
- CIN / SRHU2022386
- Keywords
- Chemotherapy induced Neuropathy, NADPH oxidase 4, 25-Hydroxy Vitamin D, Homocysteine, Vitamin B12, Proteomics profiling, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Swami Rama Himalayan UniversityUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline and after 4th cycle | – | Drug: Cisplatin, Carboplatin, Paclitaxel, DocetaxelHistopathologically 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage I-IV Solid Cancer who will receive Cisplatin or Carboplatin or paclitaxel or docetaxel as part of their standard
Key inclusion criteria (2 listed)
- All patients receiving chemotherapy for solid cancer
- Patient aged>18years
Key exclusion criteria (7 listed)
- Age ≤ 18 years
- Pre-existing neuropathy
- Patients diagnosed with Psychiatric illness
- Patients with pre-existing peripheral neuropathy
- Patients taking medication for neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin, Carboplatin, Paclitaxel, DocetaxelSolid cancer Patients receiving any one drug or in combination | Drug | Baseline and after 4th cycle |
Primary outcome
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".
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
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.
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.
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided. This will be done later with permission from research board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Himalayan Hospital(Cancer Research Institute), Himalayan Institute of Medical Sciences
Dehradun, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Swami Rama Himalayan University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and after 4th cycle of chemotherapy ( 3weekly cycle) 84 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.