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CTRI Number  CTRI/2025/10/096731 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of cryotherapy for prevention of Taxane-induced peripheral neuropathy 
Scientific Title of Study   Assessment of effectiveness of limb cooling in prevention of Taxane-induced peripheral neuropathy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Yadav 
Designation  PG (DM) Student 
Affiliation  PGIMER 
Address  Dept of Clinical hematology and Medical Oncology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9050818335  
Fax    
Email  naveeny7000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gaurav Prakash 
Designation  Prof 
Affiliation  PGIMER 
Address  Dept of Clinical hematology and Medical Oncology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209678  
Fax    
Email  drgp04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gaurav Prakash 
Designation  Prof 
Affiliation  PGIMER 
Address  Dept of Clinical hematology and Medical Oncology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209678  
Fax    
Email  drgp04@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Gaurav Prakash 
Address  Dept of CHMO PGIMER, Chandigarh 
Type of Sponsor  Other [Self Sponsored] 
 
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 
Dr Naveen Yadav  PGIMER Chandigarh  Room - 17D Dept of Clinical Hematology and Medical Oncology (CHMO)
Chandigarh
CHANDIGARH 		 9050818335

naveeny7000@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: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, (3) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (4) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (5) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cryotherapy  Cryotherapy with frozen gloves and socks put on dominant side 15min before, during and upto 15 min after the infusion of the study chemotherapy agents Nab-Paclitaxel qwkly or 3wkly and Paclitaxel qweekly 
Comparator Agent  No intervention  Non-dominant Hand and feet at ambient room temperature 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age more than and equal to 18yrs and less than 70yrs
2. ECOG PS less than equal to 2
3. Cancer patients planned for Taxane based chemotherapy.
4. A signed declaration of consent.
 
 
ExclusionCriteria 
Details  1. Prior chemotherapy exposure
2. History or clinical exam suggestive of Raynaud’s phenomenon, cold intolerance, frost bite, peripheral vascular disease.
3. Prior known neuropathy of any etiology (including but not limited to alcohol, diabetic, nutritional, connective tissue disease, porphyria, critical illness, infectious, vasculitic, compression.
4. Organ dysfunction (renal/cardiac/liver) precluding use of chemotherapy drugs under study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study difference in development of moderate to severe TIPN of CTCAE gd greater than and equal to 2 in the control and intervention arms   At start (baseline) and 12 weeks after initiation of study chemotherapy agents 
 
Secondary Outcome  
Outcome  TimePoints 
To assess change in EORTC QLQ-CIPN20 scores in control and study arm.  At baseline and at end of 12 weeks  
To assess need for omission or dose reduction in the chemotherapy protocol  At start of each chemotherapy cycle 
To compare nerve conduction study parameters in study and control arm  At baseline and 12 weeks after the start of the study chemotherapy agents 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   12/11/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgp04@gmail.com].

  6. For how long will this data be available start date provided 01-09-2027 and end date provided 30-09-2030?
    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  

CIPN is a significant and sometimes dose-limiting side effect for patients receiving certain chemotherapy agents like Platinums, Taxanes, Vinca alkaloids certain ADCs like Polatuzumab vedotin, Enfortumab vedotin. The prevalence of CIPN varies across the literature from 30-90 percent depending on the chemotherapy agent, total dose and comorbidities predisposing to neuropathies. The neurotoxic effects may persist for years in a proportion of patients, varying from 10-40 percent of those who develop CIPN. This compromises quality of life and productivity for those with prolonged remissions or who are cured of malignancy.

There are presently no drugs (with strong recommendation) for the treatment of CIPN once it develops. It is mostly managed with drug dose modification or omission. Hence, the focus has shifted to prevention of CIPN using various drugs including antidepressants, anti-epileptics, anti-oxidants, vitamins, use of physical therapies including acupuncture.

Use of cryotherapy has shown promise with conflicting evidence in reducing rates of higher grade CIPN in some research studies. These studies have primarily studied the use of cryotherapy in the prevention of TIPN, with small sample size in Japanese and Caucassian populations. There are currently no prospective randomised control trials showing the efficacy of cryotherapy in the prevention of CIPN or TIPN in the Indian population.

We wish to study the efficacy of cryotherapy in the prevention of moderate to severe CIPN (CTCAE gd greater than and equal to 2) in Indian patients receiving taxane based chemotherapy (paclitaxel or nab-paclitaxel) either alone or in combination with other non-neurotoxic agents.

 
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