| CTRI Number |
CTRI/2025/10/095576 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Hair preservation with scalp cooling in Breast and Gynecological Cancer patients receiving chemotherapy |
|
Scientific Title of Study
|
Evaluation of Scalp Cooling for Hair Preservation in Breast and Gynecologic Cancer Patients Receiving Chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 901191_Version 2.0_Dated 01.09.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anbarasan Sekar |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Medical Oncology Room No.210, Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Plot No 1 and 2 Sector 22.
Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8124227205 |
| Fax |
|
| Email |
anbarasan157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Heena Shaikh |
| Designation |
Scientific Officer C |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Radiation Oncology, Room No.205-A, Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Sector 22, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9029007867 |
| Fax |
|
| Email |
dr.shaikhheena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heena Shaikh |
| Designation |
Scientific Officer C |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
| Address |
Department of Radiation Oncology, Room No.205-A, Pay Master Shodhika, Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre, Sector 22, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9029007867 |
| Fax |
|
| Email |
dr.shaikhheena@gmail.com |
|
|
Source of Monetary or Material Support
|
| No funding required. Required Study Support will be provided by Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre Plot No. 1& 2, Sector 22. Kharghar, Navi Mumbai - 410210, Tata Memorial Centre, Dr. Ernest Borges Marg, Parel(E), Mumbai-400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)Tata Memorial Centre Plot No. 1 and 2 Sector 22 Kharghar, Navi Mumbai - 410210 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Anbarasan Sekar |
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre |
Department of Medical Oncology Room No.210, Pay master Shodhika, , Sector 22, Kharghar , Navi Mumbai - 410210
Raigarh
MAHARASHTRA |
8124227205
anbarasan157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Clinically confirmed non-metastatic breast or gynecological malignancies for curative intent.
2. Planned for anthracycline-based chemotherapy or non-anthracycline-based chemotherapy.
3. Patients taking scalp cooling. |
|
| ExclusionCriteria |
| Details |
1. Women with Common Terminology Criteria for Adverse Events version 5 .0 at baseline.
2. Alopecia grade higher than 0 at baseline.
3. History of prior chemotherapy.
4. Personal history of migraines, cluster or tension headaches, cold agglutinin disease or cold urticaria and lichen planus or lupus.
5. Concurrent active malignancies.
6. Received or will receive radiation therapy to skull. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair Preservation (less than 50 percentage of Hair loss) |
Baseline and subsequently at week 4, 6 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS) |
5 years |
| Progression-Free Survival (PFS) |
2-5 years |
| Quality of Life using EORTC QLQ-C30 |
Baseline and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
17/10/2025 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
Hair loss from chemotherapy is one of the most distressing side effects faced by cancer patients, especially women. While many side effects of chemotherapy can be managed with medication, hair loss is often overlooked—even though it can significantly affect a person’s self-image, emotional well-being, and confidence. Research shows that nearly half of women undergoing chemotherapy consider hair loss the most upsetting side effect, and some even consider refusing treatment because of it. Scalp cooling is a technique designed to reduce hair loss during chemotherapy. It works by lowering the scalp temperature using a specially designed cooling cap, which decreases blood flow and metabolic activity in the hair follicles. This helps limit the amount of chemotherapy drugs that reach the hair roots, reducing the risk of hair loss. The cooling is applied before, during, and after chemotherapy sessions. This study will assess how effective and acceptable scalp cooling is among Indian women receiving chemotherapy for breast and gynaecologic cancers. It will measure the extent of hair preservation, document patient experiences, and monitor for any side effects. Although scalp cooling is already available at our centre, results from this study may encourage more hospitals and cancer centres across India to adopt this approach. Widening access to scalp cooling could improve the quality of life and emotional well-being of many more patients undergoing chemotherapy. |