| CTRI Number |
CTRI/2020/03/023762 [Registered on: 04/03/2020] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [elsto gel frozen glove and socks ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study to assess the effect of iced gloves and socks in prevention of tingling prickling numbness and muscle weakness in hand and foot of breast cancer patients caused by paclitaxel chemotherapy injection in tertiary care cancer hospital |
|
Scientific Title of Study
|
a study to assess the feasibility safety and efficacy of frozen gloves & socks application on prevention of pacllitaxel induced peripheral neuropathy in breast cancer patient in tertiary carecancer hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEERA SHARAD ACHREKAR |
| Designation |
Professor and Deputy Nursing Superintendent |
| Affiliation |
Tata Memorial Centre |
| Address |
Advanced Centre for Treatment, Research and Education in cancer, Tata Memorial Centre
room no. 1, 13th floor, Nursing Education Department, Homi Bhabha Building. Tata memorial hospital, Parel
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769993848 |
| Fax |
|
| Email |
machrekar@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MEERA SHARAD ACHREKAR |
| Designation |
Professor and Deputy Nursing Superintendent |
| Affiliation |
Tata Memorial Centre |
| Address |
Advanced Centre for Treatment, Research and Education in cancer, Tata Memorial Centre
Room no. 1, 13th floor, Nursing Education Department, Homi Bhabha Building. Tata memorial hospital, Parel
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769993848 |
| Fax |
|
| Email |
machrekar@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
vaishali anandrao chalke |
| Designation |
2nd year M Sc. Nursing student |
| Affiliation |
tata memorial hospital parel |
| Address |
Room no.301 plot no 224/225 sai sadan near hari om mandir juinagar sect 23 navi mumbai
Room no. 1, 13th floor, Nursing Education Department, Homi
Bhabha Building. Tata memorial hospital,
Parel
Mumbai
MAHARASHTRA
400607
India |
| Phone |
9226160562 |
| Fax |
|
| Email |
chalke.vaishali21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata memorial hospital, Dr. Ernest Borges Marg, Parel |
|
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Primary Sponsor
|
| Name |
Tata memorial hospita |
| Address |
Tata memorial hospital, Dr. Ernest Borges Marg, Parel |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MEERA SHARAD ACHAREKAR |
Tata memorial hospital, Parel |
general day care and private day care
Mumbai
MAHARASHTRA |
9769993848
machrekar@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
south west technology frozen gloves and socks |
Arm-A (experimental limb i.e. dominating hand and foot)
In dominating hand and foot we will apply frozen gloves & socks (elasto gel temp is -10 to -20 degrees Celsius).
for prevention of paclitaxel induced peripheral neuropathy.
Duration for Infusion paclitaxel :45 min to 1 hour as per standard practice in case of any drug interruption
Duration for application of (elasto gel frozen gloves & socks) :45 min
And change the gloves after 45 min over.
Total paclitaxel will be administered weekly for period 12 weeks frozen gloves & socks will be applied on each cycle and safety and tolerability will be assessed on each cycle |
| Comparator Agent |
south west technology frozen gloves and socks |
Arm-B (control limb i.e. nondominating hand and foot)
Other nondominating hand and foot will be considered as control limb so No intervention will be done on the controlled side .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1.Adult >18yrs.
2.Prescribed Paclitaxel as a single or multimodal treatment for breast cancer diagnosis for 12 weeks.
3.No disorders of the nails or skin of the hand at the start of treatment
4.Able to provide informed consent in English/Hindi/Marathi/Bengali.
5.No baseline arteriovenous thrombosis/claudication or hypersensitivity disorder, allergy. |
|
| ExclusionCriteria |
| Details |
1. Previous treatment with taxane chemotherapy
2. Medical history of Reynaud’s phenomenon, distal metastases,ungual pathology,arteriopathy, cold intolerance, peripheral neuropathy of any grade.
3. Not fit for participation in the opinion of the treating oncologist/physician.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will investigate the feasibility and safety of cryotherapy, in the form of frozen gel gloves & socks, with respect to the prevention of paclitaxel-induced peripheral neuropathy in cancer patients. |
to check if the frozen gloves(temp -10 deg to -20 deg) which is to be used in the study is safe and tolerable by the patient or not at the time of administration of paclitaxel injection infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess the efficacy of frozen gel gloves & socks, with respect to the prevention of paclitaxel-induced peripheral neuropathy in cancer patients.
2) To assess the incidence and severity of peripheral neuropathy in the ice treated limb as compared to nontreated side prevention of paclitaxel induced peripheral neuropathy.
|
prevention of periphral neuropathy after 2nd cycle upto 12th cycle of weekly paclitaxel injection infusion |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/03/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
.................................................... .............. As it helps in the prevention of the paclitaxel induced peripheral neuropathy the frozen gloves and socks can be used for the patient in future for treatment |