| CTRI Number |
CTRI/2023/05/053011 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Whether cooling the scalp during chemotherapy can reduce hairfall in patients with cancer |
|
Scientific Title of Study
|
A multi-center, investigator-initiated, open label, randomized, parallel-group, superiority trial to investigate the efficacy and safety of scalp cooling system in prevention of chemotherapy induced alopecia inpatients with breast cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth G |
| Designation |
Professor of Medical Oncology |
| Affiliation |
JIPMER |
| Address |
Medical Oncology
3rd Floor SS Block
JIPMER
Dhanvantri Nagar
Puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanth G |
| Designation |
Professor of Medical Oncology |
| Affiliation |
JIPMER |
| Address |
Medical Oncology
3rd Floor SS Block
JIPMER
Dhanvantri Nagar
Puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rebekah C |
| Designation |
Research Officer |
| Affiliation |
JIPMER |
| Address |
Medical Oncology
3rd Floor SS Block
JIPMER
Dhanvantri Nagar
Puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
rebekah2023noci@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biotechnology Industry Research Assistance Council (BIRAC) |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri Nagar
Puducherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Sehrawat |
AIIMS Rishikesh |
Virbhadra Road
Rishikesh
Dehradun
UTTARANCHAL |
01352462940
dramitsehrawat@gmail.com |
| Sunu Cyriac |
Amala Institute of Medical Sciences |
Amala nagar
Thrissur
Kerala 680555
Thrissur
KERALA |
04872304170
drsunucyriac@gmail.com |
| Ashwin Phillip |
CMC Ludhiana |
Brown Road
CMC Campus
Ludhiana
Punjab
141008
Ludhiana
PUNJAB |
01612115000
drashphils23@yahoo.co.in |
| Soumya Surath Panda |
IMS and SUM Hospital |
Shampur
Bhubaneswar
Odisha
751003
Khordha
ORISSA |
06742386281
dr.ssp82@gmail.com |
| Prasanth Ganesan |
JIPMER |
Dhanvantri Nagar
Puducherry
605006
Pondicherry
PONDICHERRY |
04132296000
prasanth.g@jipmer.ac.in |
| Krishnakumar Rathinam |
Meenakshi Mission Hospital and Research Institute |
Lake Area Melur Main Road
Madurai
TN 625107
Madurai
TAMIL NADU |
04524263000
kkrathnam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh |
Approved |
| Amala Institute of Medical Sciences |
Submittted/Under Review |
| CMC Ludhiana |
Approved |
| IMS and SUM Hospital |
Approved |
| JIPMER |
Approved |
| Meenakshi Mission Hospital and Research Center |
Approved |
|
|
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 |
| Comparator Agent |
NO Scalp Cooling |
Patients in this arm will not receive scalp cooling |
| Intervention |
Scalp Cooling |
During Each Cycle of Chemotherapy patients will undergo scalp cooling by a device called EVA scalp cooling device during the duration of the chemotherapy infusion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Early and locally advanced breast cancer planned for adjuvant/ neoadjuvant chemotherapy involving anthracyclines and/ or taxanes. Patients receiving concurrent therapy with trastuzumab in Her2 positive breast cancers will be permitted to be enrolled.
Plan to complete chemotherapy within 4-6 months.
Both dose dense (every 2 weekly) and conventional (every 3 weeks) chemotherapy will be permitted
ECOG PS 0-2
Able to give informed consent.
Willing to participate in study and agree to have photographs of the head (no facial identification) taken from 5 directions at least 3 times.
Patients who choose to wear a wig will be permitted |
|
| ExclusionCriteria |
| Details |
Patients with synchronous second cancers or any other malignancy.
Patients who have already initiated chemotherapy or have already undergone chemotherapy.
Patients who have received chemotherapy in the past for any cancer must have a minimum of 2 years gap from previous chemotherapy and must have fully regrown their hair.
Preexisting hair fall, or other hair disorders like alopecia areata, skin conditions like lupus
History of brain radiation
Uncontrolled or poorly treated hypo or hyperthyroidism
History of migraine headaches
Patients with any other illness or health condition which in the opinion/medical judgment of the study investigator makes the patient ineligible to participate in the study.
Patients who have shaved their heads before starting chemotherapy.
No specific interventions for hair regrowth like serum injection etc. will be permitted, or agents like minoxidil will not be permitted.
If the head size is not properly fitting the device cap size
Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hair preservation (HP) rate |
at the end of planned adjuvant/neoadjuvant chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in quality of life using the Breast Cancer-Specific Quality of Life Questionnaire (EORTC BR 23) |
after 4 cycles of chemotherapy
end of 4 months of chemotherapy |
| adverse events due to coooling devce |
during the study after each cycle and at end of the study |
| hair regrowth |
3 months after completion of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study where patients with breast cancer who are planning to start chemotherapy will be randomly allocated to 2 groups in 2 :1 ratio. Patients in group 1 will undergo scalp cooling using a special device during the infusion of chemotherapy. Patients in group 2 will receive chemotherapy without scalp cooling. We will be assessing the patients at the end of chemotherapy to see whether scalp cooling reduced hair fall caused by chemotherapy. We will also be checking for side effects of the device and looking at hair regrowth after 3 months of completion of the treatment. Scalp cooling will be done during each session of chemotherapy. |