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
|
|
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
|
|
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 |
2 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improved ADLs |
6 |
|
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: - To develop a protocol for application of Indigenous Cryotherapy
- 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. |