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.

A randomized controlled trial to assess the incidence of lymphedema in women with breast cancer undergoing sentinel lymph node biopsy or low axillary sampling. (AiSLe) - AiSLe

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024460

Enrollment

600

Registered

2020-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Low Axillary Sampling: All women with clinically node negative early breast cancer will be randomised on study to either undergo low axillary sampling or dual dye Sentinel lymph node bi

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
To compare in both groups ï?§post op seroma formation ï?§post op shoulder dysfunction ï?§post op paresthesia rates (in the region supply of the intercostobrachial nerve) ï?§Incidence of Axilla recurrence ï?§5 year lymphedema rates 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.	—

Measure

Time frame

To compare in both groups ï?§post op seroma formation ï?§post op shoulder dysfunction ï?§post op paresthesia rates (in the region supply of the intercostobrachial nerve) ï?§Incidence of Axilla recurrence ï?§5 year lymphedema rates 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.

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Countries

India

Contacts

Public ContactDr Nita S Nair

Tata Memorial Centre

nitanair@hotmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026