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How often does arm swelling (lymphedema) occur in breast cancer patients after chemotherapy? A study comparing two surgical methods: Sentinel node biopsy vs. Axillary clearance.

Incidence of lymphedema among cT1-3N1-2M0 breast cancer patients undergoing sentinal node biopsy VS Axillary clearance after neoadjuvant chemotherapy: An ambispective observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089147
Enrollment
168
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr. Brijesh Kumar Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Disease stage: cT1-3N1-2M0 at diagnosis (prior to NACT) as per AJCC 8th edition 2)Estrogen receptor (ER) and progesterone receptor (PR)and HER2 status evaluated on primary tumour 3)Received standard NACT as per local guidelines and become cN0, Axilla imaging to assess response to NACT (as per local guidelines) 4)Undergo dual tracer sentinel lymph node biopsy (SLNB) after NACT

Exclusion criteria

Exclusion criteria: 1)Bilateral synchronous invasive breast cancer, 2)Sentinel node biopsy prior to NACT, Previous 3)Axillary nodal surgery on the same body side

Design outcomes

Primary

MeasureTime frame
Rate of arm lymphedema 1 year after surgeryTimepoint: 1 year—

Secondary

MeasureTime frame
Axillary recurrence rate, Recurrence free interval, Axillary recurrence free interval, Other locoregional recurrence rates (breast or chest wall recurrence), Rate of distant metastasisTimepoint: 1,2 and 5 years—

Countries

India

Contacts

Public ContactDr Brijesh Kumar Singh

All India Institute of Medical Sciences, New Delhi

mohitsangade1999@gmail.com9158588960

Outcome results

None listed

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