A randomized controlled study on breast cancer patients planned for surgery first with Sentinel Lymph Node biopsy or Low Axillary sampling, to understand the incidence of lymphedema.
Phase 3
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/04/024460
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Clinically node negative early breast cancer planned for upfront surgery
2. All eligible women who are willing to give informed consent.
Exclusion Criteria
1.Previous axillary surgery
2.Post neoadjuvant therapy (chemotherapy/ hormone therapy)
3.Pre-existing lymphedema
4.Previous h/o radiation to axilla
5.Previous h/o granulomatous lymphadenitis in axilla
6.Allergy to the dye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the incidence of ipsilateral lymphedema at 2 years post low axillary sampling compared to sentinel lymph node biopsy in women with clinically node negative breast cancer.Timepoint: Post-operatively, all women will undergo assessment of lymphedema at defined time points, 14 days , 6 months 12 months, 18 months 24 months , and every 6 months thereafter. the final assessment will be done after completion of recruitment.
- Secondary Outcome Measures
Name Time Method To compare in both groups <br/ ><br>ï?§post op seroma formation <br/ ><br>ï?§post op shoulder dysfunction <br/ ><br>ï?§post op paresthesia rates (in the region supply of the intercostobrachial nerve) <br/ ><br>ï?§Incidence of Axilla recurrence <br/ ><br>ï?§5 year lymphedema rates <br/ ><br>Timepoint: Post-operatively, all women will undergo assessment of lymphedema at defined time points, 14 days , 6 months 12 months, 18 months 24 months , and every 6 months thereafter.