FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/07/020436 [Registered on: 30/07/2019] Trial Registered Prospectively
Last Modified On: 29/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   prevention of lymphedema after breast cancer surgery 
Scientific Title of Study   Randomized controlled trial in comparing development of lymphedema in level 1 ALND versus complete level 3 ALND and comparing between One year administration of Benzathine Penicillin versus no Penicillin in breast cancer patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anita Dhar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  room no 5025, 5th FLoor, teaching block, Department of Surgery, Ansari Nagar,

South
DELHI
110029
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Dhar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  room no 5025, 5th FLoor, teaching block, Department of Surgery, Ansari Nagar,

South
DELHI
110029
India 
Phone  9810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jnaneshwari jayaram 
Designation  senior resident 
Affiliation  All India Institute of Medical Sciences 
Address  room no 5025, 5th FLoor, teaching block, Department of Surgery, Ansari Nagar,

South
DELHI
110029
India 
Phone  9742954025  
Fax    
Email  jnaneshwari.j@gmail.com  
 
Source of Monetary or Material Support  
department of surgery, AIIMS. NEW DELHI 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  5025, department of surgical discipline, AIIMS, New Delhi. 
Type of Sponsor  Research institution 
 
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 Anita Dhar  AIIMS  room no 5025, 5th FLoor, teaching block, Department of Surgery, Ansari Nagar,
South
DELHI 
09810198239

dranitadharbhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi, Ethics Committee  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 
Comparator Agent  conservative arm  upper limb care - teaching personal hygiene care of hands, compression stocking, manual lymphatic drainage in complete axillary lymph node dissection cases. 
Intervention  inj.benzathine penicillin 12 lakh units   inj.benzathine penicillin 12 lakh units along with level 1 Axillary lymph node dissection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1.Women above the age of 18 years with metastatic palpable axillary lymph nodes confined to level 1 with invasive breast cancer in the ipsilateral breast.
2.Locally advanced breast cancer patients who have received neoadjuvant chemotherapy.( T3N0,T3N1, )
 
 
ExclusionCriteria 
Details  1.Women with inflammatory breast cancer, skin involvement and chest wall involvement as they should undergo complete axillary lymph node dissection.
2.Pregnant women
3.Lactating women
4.Women refusing to sign consent form.
5.Patients allergic to injection Benzathine penicillin
6.Patients with advanced disease including N3, and metastatic disease.
7.Upper limb swelling with deep vein thrombosis
8.Acute infections of upper limb.
9.Refusals for consent for randomization or long follow up.
10.Patients with established upper limb lymphedema. (Pre operative difference of >2cm in both upper limbs circumference)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Risk of lymphoedema   week 4 ,8, 12, 24 and week 52 
 
Secondary Outcome  
Outcome  TimePoints 
Surgical site infection.
Quality of life score.
Arm and shoulder Pain .
Paraesthesia recorded on visual analogue scale (VAS) of 0 to 10.
Seroma in axilla.
Episodes of cellulitis and DLA in the operated upper limb.
 
week 4 ,8, 12, 24 and week 52 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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 2 
Date of First Enrollment (India)   01/08/2019 
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   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is on the rise in India and there is a dearth of awareness of the problem and its consequences in our society. Hence many patients present with advanced stage of disease where the tumor has already metastasized to the lymph nodes. Axillary lymph node status provides important prognostic information in invasive breast cancer. It is also important in staging and guiding treatment decisions. Fisher et al were the first to support the hypothesis that axillary dissection has prognostic significance . This led to the use of various options in the management of axilla including axillary lymph node dissection (ALND), axillary clearance, axillary dissection with regional lymph node radiation, regional radiation alone, axillary sampling, sentinel lymph node biopsy (SLNB) and observation .

Complete axillary dissection was considered to be a mandatory part of the surgical care of breast cancer until the 1980s. More recently, several factors have caused many practitioners to reevaluate the role of routine axillary dissection in the treatment of breast cancer . Several trials (including NSABP B-04, B-32, AMAROS, Z-0011) have shown that axillary surgery does not affect the overall survival of patients .

ALND is associated with a variety of complications like lymphedema of arm, pain/anaesthesia/paraesthesia of arm and shoulder region, seroma formation, infection, restriction of shoulder movements. Axillary ultrasonography guided FNAC accurately predicted the axillary status in 80-85% of patients and had a sensitivity of 28.5% for preoperative detection of axillary nodal metastasis.

Breast cancer related lymphedema (BCRL) is a chronic swelling of the upper limbs following surgical removal of axillary lymph nodes. It was first described by Handley in 1908 . In 1921, Halsted coined the phrase “Elephantiasis Chirurgica”. BCRL in varying degrees of severity remains a debilitating and often incurable complication of breast cancer treatment . The factors that might influence the development of secondary lymphedema after surgery are the number of lymph nodes removed, radiotherapy to the axilla, postoperative wound infection, post-surgical drainage time, lack of mobility, and obesity.

.Early, consistent, and ongoing treatment is necessary to limit the amount of extremity swelling. The conservative (nonsurgical) treatment of established lymphedema consists of a multimodality regimen, including general self-care measures (exercise, skin care), compression therapy, and physiotherapy .

Complete axillary dissection was considered to be a mandatory part of the surgical care of breast cancer until the 1980s.

Prevention is of key importance to avoid lymphedema occurrence. Treatment for lymphedema remains suboptimal and is, in most cases is palliative with a goal of preventing the disease progression rather than a cure. Medical and surgical treatments have been reported with varying successLymphedema is complicated by infection of the skin and deep tissues in approximately 40% of cases, irrespective of what is the primary etiological factor for the development of this condition. In the upper extremities after mastectomy and local irradiation, infection of the swollen limb, expressed as acute and later as chronic inflammation, ranges between 20% and 40%.

 


 
Close