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
|
|
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
|
|
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 Chirurgicaâ€. 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%. |