| CTRI Number |
CTRI/2025/12/099858 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Analytical and Open Level |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess thyroid function in Breast Cancer patients receiving Supraclavicular Radiation Therapy |
|
Scientific Title of Study
|
Prospective Study on Assessment of Thyroid Function in Breast Cancer patients receiving supraclavicular radiation therapy as a part of adjuvant therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1332-9710 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
IPGMER Kolkata |
| Address |
Room no 4 Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9161112655 |
| Fax |
|
| Email |
saurabhkumarvenvanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitabha Manna |
| Designation |
Professor |
| Affiliation |
IPGMER Kolkata |
| Address |
Room no 4 Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433009577 |
| Fax |
|
| Email |
amitavamanna1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitabha Manna |
| Designation |
Professor |
| Affiliation |
IPGMER Kolkata |
| Address |
Room No 4 Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433009577 |
| Fax |
|
| Email |
amitavamanna1965@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saurabh Kumar |
| Address |
Room no 4 Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Post Graduate Medical Education and Research Kolkata |
Department of Radiotherapy
IPGMER and SSKM Hospital
244 AJC Bose Road
Kolkata |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Kumar |
IPGMER and SSKM Hospital |
Department of Radiotherapy, IPGME&R and SSKM Hospital, 244, AJC Bose Road, Kolkata
Kolkata
WEST BENGAL |
9161112655
saurabhkumarvenvanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
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 |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients willing to participate in the study with written informed consent
2 Age 18 years to 70 years
3 Sex Females
4 Known to be suffering from Histopathologically proved Carcinoma of Breast
5 Undergone Surgery (breast conservation surgery or modified radical mastectomy) and chemotherapy
6 Eligible for Chest wall or Whole breast radiotherapy with Regional nodal irradiation including supraclavicular nodal region as part of adjuvant treatment
7 Normal haematological parameters
a Haemoglobin more than 10gm/dl (patients can be transfused before treatment to achieve this level)
b Total leucocyte count more than 4,000/cu.mm OR ANC more than 1500
c Platelet count more than 1,00,000/cu.mm
8 Normal biochemical blood parameters like LFT KFT AST or AL T less than 3 X Upper Limit of Normal
9 Normal thyroid function and anti TPO antibody negative
a Serum TSH 0.5 to 4.7 mU/L or mU/mL
b Serum free T4 10.3-35 pmol/L or 0.8 to 2.7 ng/dL
10 ECOG performance status 0 to 2
11 Patient willing to come for follow up |
|
| ExclusionCriteria |
| Details |
1 Patient who previously diagnosed with clinical or subclinical hypothyroidism.
2 Metastatic disease or Bilateral breast malignancy
3 No history of autoimmune thyroiditis or neck surgery
4 Previous history of synchronous or metachronous malignancy
5 Pregnant or Lactating women
6 Patients unable to provide subjective information.
7 Patients with collagen vascular disease or any severe uncontrolled comorbid condition which may alter treatment outcome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of hypothyroidism in breast cancer patients receiving Supraclavicular irradiation. |
Follow up visit at 4 weeks,8 weeks then 3 monthly from the completion of radiotherapy till the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study is anticipated to yield the following key results Incidence Data Quantitative assessment of how frequently hypothyroidism (clinical or subclinical) occurs post supraclavicular radiotherapy in breast cancer patients. Time Course Identification of the onset period whether acute (within weeks) or delayed (months to years) of hypothyroidism. Dose-Response Relationship Correlation between radiation dose to the thyroid gland and the likelihood of hypothyroidism, helping to establish a threshold dose. Risk Stratification Recognition of clinicopathological factors that increase susceptibility to hypothyroidism. Clinical Recommendations Proposal for routine thyroid function tests (e.g., TSH, free T4) before and after radiotherapy at defined intervals, Tailored follow-up schedules for high-risk individuals, risk-adapted modifications in radiation planning to minimize thyroid exposure and finally to render improved survivorship care. |