prevention of lymphedema after breast cancer surgery

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020436

Enrollment

320

Registered

2019-07-30

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: inj.benzathine penicillin 12 lakh units: inj.benzathine penicillin 12 lakh units along with level 1 Axillary lymph node dissection Control Intervention1: conservative arm: upper limb ca

Eligibility

Inclusion criteria

Inclusion criteria: 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, )

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Risk of lymphoedemaTimepoint: week 4 ,8, 12, 24 and week 52	—

Secondary

Measure	Time frame
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. Timepoint: week 4 ,8, 12, 24 and week 52	—

Countries

India

Contacts

Public ContactDr Jnaneshwari jayaram

All India Institute of Medical Sciences

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

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