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CTRI Number  CTRI/2025/12/098959 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can the Drug Etifoxine Safely Prevent Numbness and Pain in the Hands and Feet of Cancer Patients Caused by Drugs like Paclitaxel, Docetaxel (Taxanes) which are Used to Treat Cancer? 
Scientific Title of Study   A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Etifoxine for the Prevention of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Patients Receiving Taxane based regimen. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Syed Sharjil Anees 
Designation  Senior Resident 
Affiliation  IGIMS, Patna 
Address  Department of Pharmacology, IGIMS, Patna

Patna
BIHAR
800014
India 
Phone  9628024556  
Fax    
Email  dr.syed.pharmacology@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Syed Sharjil Anees 
Designation  Senior Resident 
Affiliation  IGIMS, Patna 
Address  Department of Pharmacology, IGIMS, Patna


BIHAR
800014
India 
Phone  9628024556  
Fax    
Email  dr.syed.pharmacology@gmail.com  
 
Details of Contact Person
Public Query  
Name  Syed Sharjil Anees 
Designation  Senior Resident 
Affiliation  IGIMS, Patna 
Address  Department of Pharmacology, IGIMS, Patna


BIHAR
800014
India 
Phone  9628024556  
Fax    
Email  dr.syed.pharmacology@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  IGIMS 
Address  Sheikhpura, Patna 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Syed Sharjil Anees  IGIMS  Clinical Pharmacology OPD, Room - 9, Porta Cabin
Patna
BIHAR 		 9628024556

dr.syed.pharmacology@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G620||Drug-induced polyneuropathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etifoxine  50 mg orally three times daily, starting 7 days before the first dose of taxane for 12 weeks 
Comparator Agent  Standard of care  Patients receive standard of care without any additional intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Scheduled to receive taxane based chemotherapy for any cancer
No pre existing peripheral neuropathy
Able to provide informed consent
Life expectancy more than 6 months 
 
ExclusionCriteria 
Details  Any pre existing disease known to cause neuropathy such as Diabetes mellitus
Family or personal history of hereditary neuropathy
Chronic Alcohol intake
Vitamin B12 deficiency
Aggressive cancers requiring urgent chemotherapy
Concurrent use of other neuroprotective agents or anxiolytics
Severe renal or hepatic impairment
Myasthenia gravis
Hypersentivity to Etifoxine
Pregnancy or breastfeeding
Unable to give informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of Grade greater than or equal to 2 Peripheral Sensory Neuropathy as per NCI CTCAE v5 at any time during the study  Follow up after each cycle of chemotherapy for 6 cycles 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline in PNQ scores  Follow up after each cycle of chemotherapy for 6 cycles 
Change in HADS scores  Follow up after each cycle of chemotherapy for 6 cycles 
Change in Numeric Rating Scale (NRS) for neuropathic pain intensity  Follow up after each cycle of chemotherapy for 6 cycles 
Adverse events and safety assessments  Follow up after each cycle of chemotherapy for 6 cycles 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.syed.pharmacology@gmail.com].

  6. For how long will this data be available start date provided 01-07-2028 and end date provided 30-06-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Introduction: Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a major, disabling side effect of cancer treatment, especially with taxanes, and currently, there are no approved drugs for its prevention. This research protocol proposes to study Etifoxine, a non-benzodiazepine anxiolytic, for CIPN prevention, based on promising results in preclinical models. Etifoxine is believed to exert its neuroprotective effects through a dual mechanism: by modulating the GABA-A receptor and by acting as a Translocator Protein (TSPO) ligand to stimulate the synthesis of neurosteroids, which mitigate processes like neuroinflammation and mitochondrial stress, suggesting its potential role beyond anxiety management and justifying its evaluation in this clinical trial.

Aim: To evaluate the efficacy and safety of Etifoxine for the prevention of clinically significant (Grade greater than or equal to 2) CIPN in adult cancer patients scheduled to receive taxane based chemotherapy.

Design and Duration: A randomized, open-label trial with a planned duration of 24 months.

Population: Adult patients with cancer, aged 18 to 75 years, who are scheduled to receive taxane based chemotherapy. Key exclusion criteria include pre-existing neuropathy (including from Diabetes mellitus), chronic alcohol intake, and use of other neuroprotective agents or anxiolytics.

Intervention:
Arm A (Experimental): Etifoxine 50 mg orally three times daily, starting 7 days before the first dose of taxane for 12 weeks.
Arm B (Control): Patients receive standard of care without any additional intervention.

Follow up: After each cycle of chemotherapy for 6 cycles.

Primary Outcome Measure: The incidence of clinically significant CIPN (Grade greater than or equal to 2) as assessed by NCI CTCAE v5.0 at any time during the study.

Secondary Objectives Include:
  1. Comparing patient reported neuropathy and functional impact using the Patient Neurotoxicity Questionnaire (PNQ).
  2. Comparing anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS).
  3. Comparing neuropathic pain intensity using the Numeric Rating Scale (NRS).
  4. Evaluating the overall safety and tolerability of Etifoxine.
Sample Size: A total of 110 patients will be recruited (n=55 per arm), accounting for a 10 percent loss to follow up. This is calculated to detect a one third relative risk reduction in the incidence of CIPN.
 
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