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CTRI Number  CTRI/2024/02/062933 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 0.4ml vs 0.6 ml India Ink Solution for tattooing of axillary lymph nodes in patients with breast cancer 
Scientific Title of Study   Comparison of 0.4 ml vs 0.6 ml diluted India ink solution for tattooing of axillary lymph nodes in the patient with breast cancer - a randomized controlled trial 
Trial Acronym  TAXLYN Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mithilesh Kumar Sinha 
Designation  Additional Professor 
Affiliation  AIIMS BHUBANESWAR 
Address  D113, cosmopolis,
Khandagiri
Khordha
ORISSA
751019
India 
Phone  9438884252  
Fax    
Email  mks132@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mithilesh Kumar Sinha 
Designation  Additional Professor 
Affiliation  AIIMS BHUBANESWAR 
Address  D113, cosmopolis,
Khandagiri
Khordha
ORISSA
751019
India 
Phone  9438884252  
Fax    
Email  mks132@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhanalakshmi N 
Designation  Junior Resident 
Affiliation  AIIMS BHUBANESWAR 
Address  Department of General Surgery AIIMS Bhubaneswar
Khandagiri
Khordha
ORISSA
751019
India 
Phone  9585662707  
Fax    
Email  dhanalakshminagesh97@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Khandagiri, Odisha 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mithilesh Kumar Sinha  AIIMS Bhubaneswar  Khandagiri, Odisha, 751019
Khordha
ORISSA 		 9438884252

mks132@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Tattooing of axillary lymph nodes with India ink 0.4 ml in patients with breast cancer.  Tattooing of axillary lymph nodes with India ink in patients with breast cancer, Stage T2-4, N1 and look for the feasibility of dissection with 0.4ml dye. 
Comparator Agent  Tattooing of axillary lymph nodes with India ink 0.6 ml in patients with breast cancer.  Tattooing of axillary lymph nodes with India ink in patients with breast cancer, Stage T2-4, N1 and look for the feasibility of dissection with 0.6ml dye 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  a) CA Breast with TNM Stage- T2-4, N1.
b) Clinically palpable axillary lymph nodes.
 
 
ExclusionCriteria 
Details  a) More than two discrete and enlarged axillary lymph nodes.
b) Axillary lymph nodes - less than 1cm (difficult to hold) and more than 5 cm (targeting not practical).
c) N stage -N2, N3.
d) Inflammatory breast cancer
e) B/L Breast cancer
f) Male breast cancer
g) Family history suggestive of BRCA1 and BRCA2 gene mutation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
comparison of Identification rates of tattooed tissue during modified radical mastectomy in two intervention arms.  During mastectomy or day 0: for identification of tattooed nodes
Follow up at daily till the day
of discharge.
10th day for stitch removal
15th day for Histopathology review.
One month: wound Evaluation
Third Month: wound and axilla review.
Sixth Month.
 
 
Secondary Outcome  
Outcome  TimePoints 
Response rate with neo- adjuvant chemotherapy  At Three months from start of chemotherapy 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 4 
Date of First Enrollment (India)   01/03/2024 
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="2"
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  

The axillary dissection is performed in breast cancer patients with metastatic axillary lymph nodes. This axillary dissection is associated with significant morbidity. The recent studies suggest that probably it can be spared in patients who have responded well to neo-adjuvant chemotherapy. In patients where nodes have disappeared targeted axillary dissection (TAD) is emerging as an alternative. Here the axillary dissection is performed only when the pre marked or the sentinel lymph nodes are positive. However, this is not universally accepted and more studies are required before inducting it into the common practice. TAD was successful in 97% of patients. We are therefore planning to find the efficacy of 0.4ml and 0.6ml India ink solution for TAD and to compare the efficacy of two different doses of the agent. To determine the optimum dose of India ink solution for TAD.

 
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