| CTRI Number |
CTRI/2026/01/100357 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of Lymphedema after Modified Radical Mastectomy |
|
Scientific Title of Study
|
Incidence of Lymphedema after Modified Radical Mastectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejinder Kaur |
| Designation |
PGJR |
| Affiliation |
Govt Medical College and Hospital, Sector-32, Chandigarh |
| Address |
Department of General Surgery Level III, D Block Government
Medical College and Hospital Sector 32A Chandigarh
Chandigarh
CHANDIGARH
160031
India Department of General Surgery Level III, D Block Government
Medical College and Hospital Sector 32A Chandigarh
Chandigarh
CHANDIGARH
160031
India Chandigarh CHANDIGARH 160031 India |
| Phone |
9876220456 |
| Fax |
|
| Email |
jhamatpooja786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Robin Kaushik |
| Designation |
Professor |
| Affiliation |
GMCH, Chandigarh |
| Address |
Department of General Surgery, Level-III, D-Block, Chandigarh
Chandigarh CHANDIGARH 160031 India |
| Phone |
9646121638 |
| Fax |
|
| Email |
robinkaushik@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Robin Kaushik |
| Designation |
Professor |
| Affiliation |
GMCH, Chandigarh |
| Address |
Department of General Surgery, Level-III, D-Block, Chandigarh
Chandigarh CHANDIGARH 160031 India |
| Phone |
9646121638 |
| Fax |
|
| Email |
robinkaushik@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh, 160031, INDIA |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of General surgery, GMCH-32, Chandigarh, 160031, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Dr Robin Kaushik |
Government medical college and hospital, Chandigarh |
Department of General Surgery, Level-III, D-Block, Chandigarh, 160031, INDIA Chandigarh CHANDIGARH |
9646121638
robinkaushik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1. All adult female patients with breast cancer undergoing Modified Radical Mastectomy.
2. All patients consenting for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients presenting with recurrent breast cancer.
2. Patients with contralateral breast cancer who have previously undergone Modified Radical Mastectomy/Radiation therapy.
3. Patients having undergone prior surgery for any upper limb condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of lymphedema in post Modified Radical Mastectomy patients |
Arm volume to be measured once at the time of admission (Baseline), 10 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/01/2026 |
| 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
|
Lymphedema is fluid buildup in the interstitial space due to impaired lymphatic drainage, often caused by surgery, cancer, radiation, or infection. Breast cancer-related lymphedema (BCRL) commonly affects the arm after treatments like axillary lymph node dissection (ALND) and/or radiation. A meta-analysis reported a 21.4% incidence of BCRL, though estimates range from 5% to 89% due to varying diagnostic criteria. Symptoms include arm swelling, heaviness, tightness, and discomfort. BCRL severity is classified based on excess arm volume: mild (<20%), moderate (20–40%), and severe (>40%). Despite advances in treatment, BCRL remains a concern, especially in patients undergoing both ALND and radiation. It can cause pain, reduced mobility, recurrent infections, and psychological issues. Diagnosis methods include limb circumference measurements, water displacement, MRI, bioimpedance spectroscopy, and perometry. A common approach is measuring arm circumference every 4 cm and calculating volume using the truncated cone formula. Early detection is key to managing BCRL effectively. |