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CTRI Number  CTRI/2018/06/014578 [Registered on: 20/06/2018] Trial Registered Prospectively
Last Modified On: 19/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of cryotherapy over routine therapy in prevention of Chemotherapy Induce peripheral Neuropathy 
Scientific Title of Study   "A Randomized Control Trial to study the effect of indigenous Cryotherapy on prevention of Chemotherapy Induced Peripheral Neuropathy (CIPN) in cancer patients receiving neurotoxic drugs attending Chemotherapy units, PGIMER, Chandigarh (2018-19)”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Sam Ila Kyndiah 
Designation  Student 
Affiliation  National Institute of Nursing Education, PGIMER, Chandigarh 
Address  National Institute of Nursing Education, PGIMER, Chandigarh
Sector 12, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9779837886  
Fax    
Email  lalakyndiah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukhpal Kaur 
Designation  Lecturer 
Affiliation  National Institute of Nursing Education, PGIMER, Chandigarh 
Address  National Institute of Nursing Education, PGIMER, Chandigarh
Sector 12, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9888536964  
Fax    
Email  drsukhpalkaur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  C Sam Ila Kyndiah 
Designation  Student 
Affiliation  National Institute of Nursing Education, PGIMER, Chandigarh 
Address  National Institute of Nursing Education, PGIMER, Chandigarh
Sector 12, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9779837886  
Fax    
Email  lalakyndiah@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical education and research, Chandigarh 
 
Primary Sponsor  
Name  C Sam Ila Kyndiah 
Address  National Institute of Nursing Education, PGIMER, Chandigarh 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
C Sam Ila Kyndiah  Chemotherapy room Radiotherapy Dept, day care (New OPD)  Post Graduate Institute of Medical Education and research, Chandigarh
Chandigarh
CHANDIGARH 
9779837886

lalakyndiah@gmail.com 
C Sam Ila Kyndiah  Chemotherapy units  Post Graduate Institute of Medical and Education Research, Chandigarh
Chandigarh
CHANDIGARH 
9779837886

lalakyndiah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cryotherapy  It involves providing gel ice packs in the form of customised mittens and socks, covering the wrists and ankles, made from an inner waterproof and an outer insulating fabric, to maintain the temperature, which is then sealed and is kept at a constant temperature. This will then be applied in the hands and feet of patients receiving chemotherapy. It will be applied 15 minutes before starting the chemotherapy administration, during the infusion period and 15 minutes after the chemotherapy administration. The gel ice packs will be changed in between to maintain the desired temperature. 
Comparator Agent  Routine treatment  calcium and magnesium supplements 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients suffering from cancer undergoing chemotherapy for the first time with neuro-toxic drugs.
2. Patients willing to participate
 
 
ExclusionCriteria 
Details  1. Known case of Peripheral neuropathy(Diabetic neuropathy, Raynaud’s syndrome, carpal tunnel syndrome)
2. Patients who are unable to report paraesthesia and pain
3. Patient ˂18 years
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Chemotherapy Induced Peripheral Outcome (CIPN) measured by NCI CTCAE criteria 
 
Secondary Outcome  
Outcome  TimePoints 
Improved ADLs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   02/07/2018 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication has been done yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The study objectives are:
  1. To develop a protocol for application of Indigenous Cryotherapy
  2. To ascertain the effect of Cryotherapy on prevention of Chemotherapy Induced Peripheral Neuropathy (CIPN) in patients receiving neurotoxic chemotherapy drugs as compared to routine therapy.
Hypothesis

H0:  There is no effect of indigenous cryotherapy on prevention of chemotherapy induced peripheral neuropathy as compared to routine therapy

HA : There is an effect of  indigenous cryotherapy on prevention  of chemo induced peripheral neuropathy as compared to routine therapy.

 

 

 
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